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Company, Product(s): GE Healthcare Aisys and Avance Anesthesia Systems
Recall Class: Class I
Date Recall Initiated: May 10, 2010
Product Names: The affected Anesthesia Systems were distributed between October 9, 2009 and October 29, 2009.
GE Healthcare Aisys and Avance Anesthesia Systems
Seeded on Thu May 13, 2010 9:44 AM EDT
Article Source: Food and Drug Administration Press Releases- Enjoy this article? Help vote it up the 'Vine.
- Public Discussion (6)
GE Healthcare Aisys and Avance Anesthesia Systems: Recall
GE and FDA notified healthcare professionals of a Class I Recall of specific lots of the Aisys and Avance Anesthesia Systems. The control board wiring harnesses have a defect which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
Healthcare professionals are encouraged to report adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Online: www.fda.gov/MedWatch/report.htm
- Phone: 1-800-332-1088
- Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch Download Forms page, to address on the pre-addressed form
- Fax: 1-800-FDA-0178
- 1 vote
#1 - Thu May 13, 2010 9:47 AM EDTCustomers were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010.
That was two months ago. They are just now issuing a recall????
It didn't say whether anyone had actually been injured or died as a result of these defective machines. Do you have any idea if there have been any injuries or deaths, Par?
- 1 vote
#2 - Thu May 13, 2010 9:58 AM EDTStephanie -
Received notice today on this - unspecified as to your question...
- 1 vote
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