Servo-i ventilator system Product Usage: Intended for treatment and monitoring of patients in the range of neonates, inf
FDA device recall Z-1362-2012 · posted 2012-04-03 · Terminated
Recall details
- Recalling firm
- Maquet Inc.
- Reason for recall
- The Servo-i and Servo-s ventilator systems equipped with specific revision os of the AC/DC convertor can result in electric shock during servicing.
- Action taken
- Maquet sent a Product Recall Urgent-Medical Device Corrective Action letter dated December 22, 2011 to all affected customers. The letter identified the affected products, patient risk, product issue and actions to be taken. Customers were instructed to complete and return the attached Customer Fax Response form as soon as possible. Maquet Field Service Technicians will update all affected products at all the concerned customer sites. Customers are advised untill Maquet has updated all the affected products (all of which are still under warranty), inform all the concerned biomedical staff about the content of this Device Correction Letter. For technical support call 1-888-627-8383.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 647 US; 2462 Foreign; 27 Spare Parts Foreign
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2011-12-22
- Date posted
- 2012-04-03
- Date terminated
- 2013-10-22
- 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 |