Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wirele
FDA device recall Z-3036-2011 · posted 2011-08-18 · Terminated
Recall details
- Recalling firm
- Spacelabs Healthcare, Llc
- Reason for recall
- Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem.
- Action taken
- Spacelabs Medical sent an "URGENT - MEDICAL DEVICE CORRECTION" notification letter to U.S. consignees by mail on September 17, 2010 and to international consignees by e-mail on September 24, 2010. The letter identified the recalled product, warns customers of the potential hazard and identifies some ways to mitigate the risk if they decide to continue use. The letter states to correct this situation, the recalling firm Field Service Engineers will be contact customers to schedule a time to install a free software update. If customers have any questions about this corrective action program, please contact Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 579 total (517 to US acc'ts; 62 to international acct's.
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of: International distribution to: Canada, China, France, Germany, Italy, and the United Kingdom.
- Date initiated
- 2010-09-17
- Date posted
- 2011-08-18
- Date terminated
- 2011-08-22
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS MEDICAL PCIS PATIENT MONITORS (K972282) | Spacelabs Medical, Inc. | 1997-09-25 |