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.
FDA Recall Z-0196-2013 · Posted 2012-11-05
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Recalling FirmSpacelabs Healthcare, Llc
Recall StatusTerminated
Product CodeMHX
Date Initiated2012-10-05
Date Terminated2013-03-25
Product Quantity169 units distributed (98 in US and 71 Internationally)
Reason for Recall
Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation.
Firm 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 about this recall.
Root Cause
Vendor change control
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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