Maquet Servo-i ventilator system Device Part number 64 87 800 Intended for treatment of and monitoring of patients in ra
FDA device recall Z-0352-2012 · posted 2011-12-02 · Terminated
Recall details
- Recalling firm
- Maquet Inc.
- 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).
- Action taken
- 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.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 166 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2011-09-19
- Date posted
- 2011-12-02
- Date terminated
- 2015-07-22
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K041223) | Maquet Critical Care AB | 2004-07-29 |