Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are ge
FDA device recall Z-2382-2012 · posted 2012-09-14 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- There is a potential failure of the Integrated Module Housing causing the patient module parameters to drop off the monitor display or the patient module will fail to sign on when inserted into the housing.
- Action taken
- Spacelabs Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated August 27, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-800-522-7025 and select 2 for assistance regarding this recall.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 527 units total; 350 US and 177 International
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-08-27
- Date posted
- 2012-09-14
- Date terminated
- 2013-04-15
- Location
- Issaquah, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS ALPHA PC PATIENT COMPUTER (K842616) | Spacelabs, Inc. | 1984-10-18 |