Date Initiated by Firm |
May 23, 2006 |
Date Posted |
January 25, 2007 |
Recall Status1 |
Terminated 3 on April 11, 2008 |
Recall Number |
Z-0372-2007 |
Recall Event ID |
37089 |
510(K)Number |
K010925
|
Product Classification |
ventilator - Product Code CBK
|
Product |
Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care |
Code Information |
Article # 64-87-800 Serial numbers 02400 - 03300 |
Recalling Firm/ Manufacturer |
MAQUET Inc. 1140 US Highway 22 Bridgewater NJ 08807-2958
|
For Additional Information Contact |
Jamie Yieh 908-947-2311
|
Manufacturer Reason for Recall |
Reported failures of the SERVO-i ventilators user interface system causing technical errors and increased fault frequencies. Switches may be activated unintentionally, or a function not activate when the switch is selected. Direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.
|
FDA Determined Cause 2 |
Other |
Action |
Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications. |
Quantity in Commerce |
1, 970 units |
Distribution |
Worldwide |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = CBK and Original Applicant = SIEMENS ELEMA AB
|