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.
- 2019-02-27FDA-DeviceOrtho Clinical Diagnostics IncClass IIVitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of myoglobin in human serum and plasma
A stability issue in the calibrators may cause calibration failures or atypical Quality Control results following a successful calibration.
- 2019-02-27FDA-DeviceSmiths Medical ASD Inc.Class IIAplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
- 2019-02-27FDA-DeviceSmiths Medical ASD Inc.Class IIAplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating.
- 2019-02-27FDA-DeviceIntuitive Surgical, Inc.Class IIdaVinci Harmonic ACE Curved Shears
During an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE Inserts may become damaged during transit. The potential damage includes pinholes and /or small openings (less than a few millimeters) on the pouch leading to a potential breach in sterility.
- 2019-02-27FDA-DeviceRandox Laboratories Ltd.Class IIRandox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1, Arsenazo Reagent 4 x 20 ml GTIN: 05055273208368
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
- 2019-02-27FDA-DeviceRandox Laboratories Ltd.Class IIRandox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871, R1. Arsenazo Reagent 9 x 51ml GTIN: 05055273200904
Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calcium reagent results may result in falsely elevated or decreased results to both patient and QC samples.
- 2019-02-27FDA-DeviceLeica Microsystems, Inc.Class IIPROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.
- 2019-02-20FDA-DeviceOMNIlife science Inc.Class IIOMNI K1 Broach Handle, Product Code HS-10054
There is a potential for the inner pin of the handle to become loose and fall out.
- 2019-02-20FDA-DeviceThe Magstim Company LimitedClass IIHORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.
- 2019-02-20FDA-DeviceEdwards Lifesciences, LLCClass IIEdward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690103193961 9600LDS29J 00690103194883 9610TF20 00690103192995 9610TF23 00690103190458 9610TF26 00690103190465 9610TF29 00690103193008 Product Usage: The Edwards SAPIEN 3 THV, Edwards Commander delivery system an
This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
- 2019-02-20FDA-DeviceSignature Orthopedics Pty LimitedClass IIGenius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
Product mix up
- 2019-02-20FDA-DeviceSignature Orthopedics Pty LimitedClass IIGenius Knee Cemented Tibial Component Product Usage: Knee replacement component
Product mix up
- 2019-02-20FDA-DeviceAtriCure, Inc.Class IICOBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
- 2019-02-20FDA-DeviceAtriCure, Inc.Class IICOBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
- 2019-02-20FDA-DeviceAtriCure, Inc.Class IICOBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
- 2019-02-20FDA-DeviceAtriCure, Inc.Class IICOBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.
- 2019-02-20FDA-DeviceOttobock Orthopedic IndustrieClass II21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
Some of the installed valve-inserts have a diameter smaller than the specification.
- 2019-02-20FDA-DeviceOttobock Orthopedic IndustrieClass II21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
Some of the installed valve-inserts have a diameter smaller than the specification.
- 2019-02-20FDA-DeviceOttobock Orthopedic IndustrieClass II21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
Some of the installed valve-inserts have a diameter smaller than the specification.
- 2019-02-20FDA-DeviceCincinnati Sub-Zero Products LLC, a Gentherm CompanyClass IIHemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The Hemotherm Dual Reservoir Cooler/Heater may also be used with a hyper / hypothermia blanket under the patient to provide warming through condu
Evidence supports that when customers performed a fuse replacement as part of a March 2017 field action, the fuse clips became stretched and were no longer mechanically tight with the fuse, creating a host spot that led to discoloration on the board due to overheating and shut down of the device.
- 2019-02-20FDA-DeviceSteris CorporationClass IIATLAS Loading Car
The ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side.
- 2019-02-20FDA-DevicePhilips Medical Systems (Cleveland) IncClass IIIngenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imagin
A software update is being issued to correct multiple issues identified in the previous software version.
- 2019-02-20FDA-DeviceLuminex CorporationClass IIIVergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture s
On lot of VERIGENE(R) BC-GP Utility Kits (20-011-018) were labeled with the VERIGENE(R) Amplification Tray label.
- 2019-02-20FDA-DeviceElekta, Inc.Class IIMOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
There is a potential that Wedge IDs were not included in the DICOM RT PLAN sent from the TPS, which will cause the field in MOSAIQ to be created with no wedge. Treatment of a field without the planned wedge will receive more dose than the treatment plan indicates.
- 2019-02-20FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class Ivitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
- 2019-02-20FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IMedtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
- 2019-02-20FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IMedtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
- 2019-02-20FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IMedtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
- 2019-02-20FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IMedtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
- 2019-02-20FDA-DeviceMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)Class IMedtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality
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