| Class 1 Device Recall GE Avance | |
Date Initiated by Firm | March 12, 2010 |
Date Posted | May 11, 2010 |
Recall Status1 |
Terminated 3 on January 30, 2012 |
Recall Number | Z-1527-2010 |
Recall Event ID |
55355 |
510(K)Number | K081844 |
Product Classification |
Anesthesia Machine and Monitor - Product Code BSZ
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Product | GE, 1009-9002-000 Avance Anesthesia Machine and Monitor |
Code Information |
Serial Numbers: ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289 |
Recalling Firm/ Manufacturer |
Ge Healthcare, Llc 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 262-544-3894 |
Manufacturer Reason for Recall | Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring. |
FDA Determined Cause 2 | Process design |
Action | Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 12, 2010. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager, Director of Biomedical/Clinical Engineering.
The letter listed the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. |
Quantity in Commerce | 18 (4 USA, 14 OUS) |
Distribution | Worldwide distribution: USA (CA, FL, TN), CANADA, DENMARK, FINLAND, FRANCE, ITALY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, UNITED ARAB EMIRATES, and UNITED KINGDOM. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = BSZ
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