Recall Z-1177-2013 ยท CBK Ventilator, Continuous, Facility Use
Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which au
| Date | Apr 26, 2013 (initiated Mar 7, 2013) |
| Status | Terminated |
| Reason | When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected. |
| Root cause | Device Design |
| Action | The firm, Maquet Getinge Group" sent "Field Safety Notices"/"Field Safety Notice Confirmation Forms" dated March 7 & 11 2013 via Federal Express and an updated Field Safety Notices dated April 15, 2013 to its customers. The Field Safety Notices identifies the problem, product, risk factors and actions to be taken by the customer. The customers were instructed to reconnect the ventilator to mains power immediately or add additional battery modules in case of 'low battery voltage' alarm; ensure that at least two fully charged batteries are installed at all times, and that sufficient resuscitati |
| Quantity | 90,000 units (batteries) |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH RE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041223 | MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E Maquet Critical Care AB, Jul 29, 2004 |