Date Initiated by Firm | September 19, 2011 |
Date Posted | December 02, 2011 |
Recall Status1 |
Terminated 3 on July 22, 2015 |
Recall Number | Z-0353-2012 |
Recall Event ID |
60338 |
510(K)Number | K041223 |
Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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Product | Maquet Servo-S ventilator system
Device Part number 66 40 440
Intended for treatment of and monitoring of patients in range of neonates, infants and adults with respiratory failure of respiratory insufficiency; used only by healthcare providers in hospitals or healthcare facilities and for in hospital transport. |
Code Information |
Device Part number 66 40 440 Lot number S/N 16783-17318 510 k 041223 Device Listing No. B052264 |
Recalling Firm/ Manufacturer |
Maquet Inc. 45 Barbour Pond Drive Wayne NJ 07470
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For Additional Information Contact | Ms. Whitney Torning 973-709-7660 |
Manufacturer Reason for Recall | Servo-I and Servo--S ventilator systems are equipped with a specific revision of a printed circuit board (PC1772 revision 22) that includes a component that has generated a number of nuisance alarms due to technical error message 24 (TE 24). |
FDA Determined Cause 2 | Vendor change control |
Action | The firm, Maquet Getinge Group, sent an " PRODUCT RECALL URGENT - MEDICAL DEVICE CORRECTIVE ACTION" letter dated September 19, 2011, to its customers. The letter describes the product, problem and actions to be taken. Maquet service team will contact the customers within two weeks of receiving this letter to schedule an on-site service of the affected equipment.
If you have any questions, call technical support at our toll free number at 1-888-627-8383. |
Quantity in Commerce | 26 units |
Distribution | Nationwide distribution. |
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 = CBK
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