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.
This recall has been terminated (originally issued December 2, 2011).
- Company
- Maquet Inc.
- Recall Initiated
- September 19, 2011
- Posted
- December 2, 2011
- Terminated
- July 22, 2015
- Recall Number
- Z-0353-2012
- Quantity
- 26 units
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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).
Distribution
Nationwide distribution.
Lot / Code Info
Device Part number 66 40 440 Lot number S/N 16783-17318 510 k 041223 Device Listing No. B052264
Root Cause
Vendor change control
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.