Medical equipment, implants, and diagnostic devices
GE Medical Systems, SCS
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
GE Medical Systems, SCS
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
Ultrasound system with: 1) transesophageal echocardiography transducer (TEE) connected/not selected 2) 1, 2 non-TEE connected 3) Imaging with non-TEE 4) Selected/not selected imaging transducer removed 5) Transducer connected 6) Non-TEE imaging continues, Then though TEE is unselected, it may have power, no temperature monitoring/control, and may result in temperature above limit and patient burns
GE Medical Systems, SCS
GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Baxter Healthcare
One device was improperly performed testing prior to release from a Service Center.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
Stryker Leibinger GmbH & Co. KG
Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
XXX
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low current electrical shock to the user.
Cardinal Health 200
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
Johnson & Johnson Surgical Vision
Due to a manufacturing variation of the irrigation sleeves which could result in a missing port hole, this non-conformity could lead to insufficient flow to cool the ultrasonic phaco tip, potentially leading to an unstable anterior chamber which could cause possible harms.
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
RAYSEARCH LABORATORIES AB
Potential for reported SSD to be too high.
54 MM finisher blade was inadvertently affixed to the shaft of the CupX handle in lieu of the 54 MM starter blade.
IVOCLAR VIVADENT AG
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Cardinal Health 200
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.