The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (
FDA device recall Z-0196-2013 · posted 2012-11-05 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.
- Action taken
- Spacelabs Healthcare sent a URGENT - MEDICAL DEVICE CORRECTION letter dated October 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are advised to advise their staff of this potential failure and advise them to ensure the alarm lights are functional. The firm will contact the consignee at the earliest possible date to schedule a convenient time for the hospital to upgrade the affected product at no cost. Customers can call Technical Support at 1-800-522-7025 and select 2 for any questions about this recall.
- Root cause
- Vendor change control
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 169 units distributed (98 in US and 71 Internationally)
- Distribution
- Worldwide Distribution--US (nationwide) including states of Alaska, California, Florida, Illinois, Michigan, South Carolina, and Texas., and the countries of Canada, Chile, France, Libya, Panama, Qata
- Date initiated
- 2012-10-05
- Date posted
- 2012-11-05
- Date terminated
- 2013-03-25
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) (K112962) | Spacelabs Medical, Inc. | 2011-11-02 |