Maquet PC Board PC1772 Spare Part Device Part number 64 67 620 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.
Recall
- Recall Number
- Z-0354-2012
- Event Number
- 60338
- Firm
- Maquet Inc.
- FEI Number
- 3008355164
- Product Code
- CBK
- Status
- Terminated
- Root Cause
- Vendor change control
- Initiated
- September 19, 2011
- Posted
- December 2, 2011
- Terminated
- July 22, 2015
- Address
- 45 Barbour Pond Drive, Wayne, NJ, 07470
Description
Maquet PC Board PC1772 Spare Part Device Part number 64 67 620 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.
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).
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.
Nationwide distribution.
10 units