Medical device recalls
39226 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2019-05-15FDA-DeviceCardinal Health 200, LLCClass IIChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- 2019-05-15FDA-DeviceCardinal Health 200, LLCClass IIChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- 2019-05-15FDA-DeviceCardinal Health 200, LLCClass IIChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- 2019-05-15FDA-DeviceCardinal Health 200, LLCClass IIChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- 2019-05-15FDA-DeviceMedtronic Inc.Class IIGuardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
- 2019-05-15FDA-DeviceAlpha Omega EngineeringClass INeuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue.
If cables are improperly connected, current may reach high charge density, causing tissue harm.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IIOptima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IINM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitori
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IINM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for stand
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IINM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body and vascular X-ray Comp
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IINM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IINM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM operation con
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and f
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceGE Healthcare, LLCClass IIDiscovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The main components of the Discovery NM 630 system are: NM Gantry with Dual detector heads, patient table, Remote Control Unit and NM ope
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
- 2019-05-08FDA-DeviceLin-Zhi International IncClass IIIEthyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradation in EtOH assay. Possible container or pitchers with some detergent residue was used while producing R2 of the defective lot.
Shelf life of the product may be reduced due to degradation of the assay.
- 2019-05-08FDA-DeviceRandox Laboratories Ltd.Class IIG-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
The target values and ranges in these lots are incorrect.
- 2019-05-08FDA-DeviceRandox Laboratories Ltd.Class IIG-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
The target values and ranges in these lots are incorrect.
- 2019-05-08FDA-DeviceCarolina Liquid ChemistriesClass IIICAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
Supplier testing showed that the absorbance rate of the Ethyl Alcohol Assay did not meet internal quality control specifications. The defective lots will not function toward the end of shelf life.
- 2019-05-08FDA-DeviceCarolina Liquid ChemistriesClass IIICAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
- 2019-05-08FDA-DeviceViewray, Inc.Class IIMRIdian Linac Radiation Therapy System, Model 20000.
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
- 2019-05-08FDA-DevicePhilips North America, LLCClass IIFetal Spiral Electrode, Model No. 9898 031 37631
During use of the Philips FSE, it is possible for the metal electrode tip to break off and remain in the scalp of the newborn following labor and delivery.
- 2019-05-08FDA-DeviceRoche Diagnostics CorporationClass IIcobas e 801 immunoassay analyzer
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
- 2019-05-08FDA-DeviceBaxter Healthcare CorporationClass IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epi
The flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.
- 2019-05-08FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
- 2019-05-08FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
- 2019-05-08FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
- 2019-05-08FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube.
- 2019-05-08FDA-DeviceMolnlycke Health Care, IncClass IIEZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ De
Intermittent heat seal failures on the outer pouch of some EZ Derm products.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief