Medical equipment, implants, and diagnostic devices
Philips Medical Systems Gmbh, DMC
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.
Philips Medical Systems Gmbh, DMC
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.
Zimmer Biomet
Product was manufactured from the incorrect material, which shows a potential decrease in the fatigue strength of the connecting bolt that can lead to fracture.
Missing desiccant.
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
Vyaire Medical
Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.
Philips Medical Systems Gmbh, DMC
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
GE Healthcare has identified that some CT systems may have a damaged cable that can expose 120VAC to Service Engineers working inside the gantry.
Philips Medical Systems Gmbh, DMC
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.
Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
ICU Medical de Mexico, S.A. de C.V.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
ICU Medical de Mexico, S.A. de C.V.
ICU Medical is expanding the scope of their previously initiated recall to include additional I.V. Administration Sets with NanoClave manifold due to the potential to develop a leak or for separation between the female luer and the NanoClave manifold.
Merit Medical Systems
Supplier manufacturing defect with the syringe plunger tip.