Recall Z-3036-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a
| Date | Aug 18, 2011 (initiated Sep 17, 2010) |
| Status | Terminated |
| Reason | Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem. |
| Root cause | Software design |
| Action | 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, |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972282 | SPACELABS MEDICAL PCIS PATIENT MONITORS Spacelabs Medical, Inc., Sep 25, 1997 |