Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2018-05-09FDA-DeviceAmeditech IncClass IIIAlere iScreen Dx Urine Drug Screen Card
The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box.
- 2018-05-09FDA-DevicePerkinElmer Life and Analytical Sciences, Wallac, OYClass IISpecimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
- 2018-05-09FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
May produce erroneously low results from specific well sets.
- 2018-05-09FDA-DeviceBeaver-Visitec International Inc.Class IIWET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
- 2018-05-09FDA-DeviceZimmer Biomet, Inc.Class IIModular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
- 2018-05-09FDA-DeviceZimmer Biomet, Inc.Class IIModular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser UL Station surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser Nice Station Light Based Platform surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser UL C02 Laser surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser Trixel 11 C02 Laser surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser Trixel C02 Laser surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceBeijing Syntech Laser Co., LtdClass IIBeijing Syntech Laser Diode Laser surgical lasers
The noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-09FDA-DeviceSiemens Medical Solutions USA, IncClass IISOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
To inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure
- 2018-05-02FDA-DeviceSmith & Nephew, Inc.Class IISmith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
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