Recall Z-2134-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, 90496, & 91496. Affected model number is 91387 shipped after February 10, 2010 with PCBA 670-1298-01 (serial numbers beginning with 1387-1xxxxx). The data sheet is labeled in part: "***91387-27 SL2700 Patient Monitor***91387-28 SL2800 Advanced Patient Monitor***91387-38 SL3800 Central Monitor***
| Date | May 3, 2011 (initiated Mar 24, 2011) |
| Status | Terminated |
| Reason | The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and customers may lose any changes they have made to the alarm settings. |
| Root cause | Other |
| Action | SPACELABS Healthcare sent an Urgent Medical Device Correction letter dated April 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to weigh the benefits versus the risks when deciding whether or not to continue to use their monitors until they can be upgraded. Customers were recommended to brief their staff about the possibility of losing changes to the alarm settings and to restore them after a power interruption. Field service engineers will contact customers to schedule a mutually |
| Quantity | 4470 units total (1894 units in US and 2579 units internationally) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, BOLIVIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, EGYPT, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, INDONESIA, IRAQ, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102422 | SPACELABS MEDICAL PATIENT MONITORS Spacelabs Medical, Inc., Dec 7, 2010 |