The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Class I - Dangerous
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class I - Dangerous
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
Leica Biosystems Melbourne Pty
Class I - Dangerous
There is a leakage issue associated with the tubing in the manifold of the instrument.
GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200
GE Medical Systems China Co.
Class I - Dangerous
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
Medline procedure kits, labeled as: HAND, REF DYNJ902002J
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Description: CELL-DYN Ruby Component: No
Abbott Laboratories
Class I - Dangerous
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Philips Medical Systems Nederland B.V.
Class I - Dangerous
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Philips North America
Class I - Dangerous
Unintended motion issues related to Interventional Control that may lead to collision of the Gantry/table with the operator or patient.