Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhy
FDA device recall Z-2019-2012 · posted 2012-07-16 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor.
- Action taken
- Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated June 29 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to advise their staff of the potential failure of the XPREZZON Bedside Monitor. Spacelabs will contact customers to schedule a convenient time for their hospital to upgrade their affected monitors, at no cost. On July 6 2012, a customer letter (translated as necessary) URGENT - MEDICAL DEVICE CORRECTION Spacelabs Healthcare XPREZZON Bedside Monitor will be emailed to all international subsidiaries and distributors of record. Customers with questions can contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support. For questions regarding this recall call 800-522-7025, ext 2.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 21 units
- Distribution
- Worldwide Distribution - USA including Florida, Iowa, Oklahoma, South Caroline and the countries of India, Germany and Panama.
- Date initiated
- 2012-06-12
- Date posted
- 2012-07-16
- Date terminated
- 2012-11-28
- 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 |