SwitchPoint Infinity Control System Stryker Communications, 1410 Lakeside Parkway, # 100, Flower Mound, TX 75208 The Swi
FDA device recall Z-0136-2012 · posted 2011-10-28 · Terminated
Recall details
- Recalling firm
- Stryker Communications Corp
- Reason for recall
- Installation records for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems are incomplete or inadequate.
- Action taken
- Stryker sent an URGENT FIELD SAFETY NOTICE: RA2010-245 dated August 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the attached Customer Response Form within 5 business days to Stryker. A Stryker representative would contact them at their convenience to schedule a re-inspection for all of the units identified and still in use. In the event the inspected equipment does not meet Stryker's established specifications, their representative will visit their facility and hopefully resolve the issue. If a subsequent visit is required the date will be scheduled in full consideration of their services. For questions regarding this recall call 972-410-7310.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FSY
- Distribution
- Worldwide Distribution including Puerto Rico, Brazil, Ecuador, Venezuela, Costa Rico, Bolivia, Peru, Mexico, China, India, Korea, Philippines, Singapore, Malaysia, Taiwan, Middle East, Russia, Africa,
- Date initiated
- 2011-08-23
- Date posted
- 2011-10-28
- Date terminated
- 2012-08-20
- Location
- Flower Mound, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISUM LED SURGICAL LIGHTING SYSTEM (K060802) | Stryker Communications Corp. | 2006-04-07 |