GE Healthcare MR superconducting magnets, a component of GE Healthcare Optima MR430s System recall — FDA Z-0620-2022
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Complete FDA and NHTSA recall records dated in 2022, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
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…
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Error messages 206 (yellow) and 208 (red) technical failure, flow measurement during use of the Novalung System imply that the communication between flow sensor and sensor box is…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The chrome surface of the push brace can crack during use, potentially cutting the user.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone…
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
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…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.