XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the surgical field or for the examination o
FDA device recall Z-0186-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.
- Action taken
- Urgent Device Correction letters, dated October 7, 2009, were sent out by FedEx. The letter identified the affected products and asked customers to call 1-888-627-8383 #1, if they have any questions. The letter also provided a Technical Description along with a Customer Fax Response form. The letter stated the potential hazard and recommended precaution. If customers need additional info or have any questions they should contact their local MAQUET representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FSY
- Quantity affected
- 54
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-10-07
- Date posted
- 2009-11-12
- Date terminated
- 2012-06-04
- Location
- Bridgewater, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALM X'TEN (X10) SURGICAL LIGHT SYSTEM (K040735) | Alm S.A. | 2004-05-21 |