SERVO-s Ventilator System, Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of
FDA device recall Z-2443-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- Maquet became aware of potentially defective crimpings at the point connector attached to the cable in SERVO-i and SERVO-s ventilators.
- Action taken
- Urgent - Device Correction notices were sent out to all customers on July 7, 2008. The letter informed the customers of the affected product, and associated hazards. The letter instructed customers to take an inventory of the product and it provided actions to be taken until affected products are replaced. Contact Maquet at 1-888-627-8383#1, for assistance.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 122 total (SERVO-i and SERVO-s) in US.
- Distribution
- Worldwide.
- Date initiated
- 2008-07-08
- Date posted
- 2008-09-23
- Date terminated
- 2008-12-23
- Location
- Bridgewater, 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 |