SwitchPoint Element (SPE) Control System. Control System for audio/video, surgical, and room equipment. Catalog Numbers:
FDA device recall Z-1643-2010 · posted 2010-05-21 · Terminated
Recall details
- Recalling firm
- Stryker Communications Corp
- Reason for recall
- Installation records are incomplete.
- Action taken
- An Urgent: Medical Device Product Correction customer notification letter, dated 4/15/2010, has been sent out to all affected accounts via regular mail in the form of a certified, return request receipt letter. Accounts will receive a follow-up phone call from a Stryker Representative to schedule a re-inspection of equipment to see if it mets established critical specifications or not. The firm recommends that customers continue using all Stryker Communications products listed in the notice. Questions can be directed to Katie Blackwell at 972-410-7660 or via email at StrykerCommunicationsRA@stryker.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 9
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-04-15
- Date posted
- 2010-05-21
- Date terminated
- 2011-01-24
- Location
- Flower Mound, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER SWITCHPOINT INFINITY (K033132) | Stryker Communications Corp. | 2004-09-02 |
| STRYKER VISUM SURGICAL LIGHTING SYSTEM (K031068) | Stryker Endoscopy | 2003-08-12 |