Medical device recalls
38751 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355 System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Brivo MR355/Optima MR360 System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare 1.5T SIGNA HDe MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE 0.7T SIGNA OpenSpeed with Excite MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA OpenSpeed MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA HFO/I MR System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Infinity MR System, SIGNA Infinity MR System with Excite Technology, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA 1.5T TwinSpeed MR System, nuclear magnetic resonance system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE 1.5T SIGNA HDx MR System, GE 3.0T SIGNA HDx MR System, GE 1.5T SIGNA HDxt MR System, GE 3.0T SIGNA HDxt MR System, 1.5T SIGNA HDxt, 3.0T SIGNA HDxt, 1.5T SIGNA HDxt Mobile, 3.0T SIGNA HDxt Mobile, SIGNA HDi, SIGNA Vibrant systems, nuclear magnetic resonance imaging systems.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR450 1.5T system, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR450w 1.5T, Optima MR450w GEM system, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Voyager and SIGNA Voyager Premier Edition system, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR355 and SIGNA MR360 System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Creator and SIGNA Explorer System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750 3.0T System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare Discovery MR750w 3.0T System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Pioneer System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Architect system, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceGE Healthcare, LLCClass IIGE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Premier System, nuclear magnetic resonance imaging system.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIQC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIQC Sets and Panels, KWIK-STIK AST-GP (6 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIQC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IILYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIKWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIQC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Comprehensive QC Set. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubatio
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IILYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements.
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
- 2022-02-16FDA-DeviceMicrobiologics IncClass IIKWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover
Potential contamination with S. epidermidis E. coli and S. warneri.
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