Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
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.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Microbiologics
Class I - Dangerous
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.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.