Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use wit
FDA device recall Z-1177-2013 · posted 2013-04-26 · Terminated
Recall details
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Reason for recall
- 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.
- Action taken
- 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 resuscitation equipment is accessible to the ventilator; identify and immediately replace battery modules with date codes 1005-1243, that have generated either: a "low battery voltage" alarm or a "replace battery" message, prior to the expiry date; and complete and return the enclosed Field Safety Notice Confirmation Form by e-mailing a scanned copy to FieldActions@maquet.com or via fax at (973) 807-1832. If you have any questions or require replacement batteries, please contact your local MAQUET representative, or MAQUET Customer Service at 888-627-8383 (press option 2, followed by option 3) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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,
- Date initiated
- 2013-03-07
- Date posted
- 2013-04-26
- Date terminated
- 2016-08-11
- Location
- Wayne, NJ
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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 |