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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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
37,779 Total Recalls
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA MR380 System, nuclear magnetic resonance system.
GE Healthcare
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484
Baxter Healthcare
Class I - Dangerous
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 may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484
Baxter Healthcare
Class I - Dangerous
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 may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
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 chrome surface of the push brace can crack during use, potentially cutting the user.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Class I - Dangerous
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 interrupted. An interrupted communication between flow sensor and sensor box might lead to a disabled flow measurement and air bubble detection.
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.
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482
Baxter Healthcare
Class I - Dangerous
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 may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Class I - Dangerous
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ
Baxter Healthcare
Class I - Dangerous
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 may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
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.
Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483
Baxter Healthcare
Class I - Dangerous
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 may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
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.
CURAD REUSABLE GEL HOT/COLD PACK
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
The product contains natural rubber latex but the label states that it does not.