Ultraview SL Command Module, Model 90496 The product is intended for use with the Patient Care Monitoring System (PCMS)
FDA device recall Z-2342-2008 · posted 2008-09-19 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Incorporated
- Reason for recall
- Potential for module to fail to obtain a NIBP reading on hypertension patients.
- Action taken
- On July 22, 2008 an "Urgent MEDICAL DEVICE CORRECTION" letter was mailed to all the firm's customers. The letter states the problem at hand, when the problem would likely to occur and instructions of a way to mitigate the risk, until the modules can be recalibrated . The firm's Customer Connectivity Center will confirm all affected customers have been notified. Spacelabs Technical Support will be recalibrating all modules personally and ensuring all corrections have been applied to all affected customers of record. Contact Spacelabs Healthcare at 1-800-522-7025 for assistance.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DSI
- Quantity affected
- 5,140
- Distribution
- The product is distributed nationwide and internationally to medical facilities.
- Date initiated
- 2008-07-22
- Date posted
- 2008-09-19
- Date terminated
- 2011-07-25
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 (K972502) | Spacelabs Medical, Inc. | 1998-05-28 |