Recall Z-0196-2013 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules.
| Date | Nov 5, 2012 (initiated Oct 5, 2012) |
| Status | Terminated |
| Reason | Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. |
| Root cause | Vendor change control |
| Action | 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 abo |
| Quantity | 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, Qatar, Saudi Arabia, Switzerland and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112962 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) Spacelabs Medical, Inc., Nov 2, 2011 |