ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumin
FDA device recall Z-1153-2009 · posted 2009-04-12 · Terminated
Recall details
- Recalling firm
- MAQUET Inc.
- Reason for recall
- The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.
- Action taken
- An "Urgent Device Correction" letter dated February 23, 2009 was mailed by FedEx Tracking to all affected consignees. The letter described the issue, potential hazard and recommended precaution. Customers were instructed to complete the enclosed "Customer Response Fax Form" and return it via fax (1-732-667-1903) to Maquet, Inc. Maquet, Inc. will schedule repair service of the affected units once the "Customer Response Fax Form" is received. Direct questions to your local Maquet, Inc. Representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FTD
- Quantity affected
- 54 of all units, both article numbers
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-02-23
- Date posted
- 2009-04-12
- Date terminated
- 2009-09-29
- 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 SURGICAL LAMPS (K882613) | Alm Surgical Equipment, Inc. | 1988-07-18 |