Recall Z-2707-2014 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare Inc
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data genera
| Date | Sep 25, 2014 (initiated Aug 26, 2014) |
| Status | Terminated |
| Reason | The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls since 2011 and discovered 222 additional serial numbers were missed and were not included in the previous recall under RES 59456 (recall number Z-3032-2011). |
| Root cause | Environmental control |
| Action | Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION (Expanded)" letter dated 5 September 2014 to all consignees in the US. This letter identified recalled model 91367, 91369, 91370, 91387, and 91393, Upgrade Kit 040-1548-00, Equipped with the Perioperative Option (-D), problem, and actions to be taken. On September 12, 2014, a recall notification letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. The notification letter stated that the Operating Room staff may not be aware that alarm tones are off if the device has been left in th |
| Quantity | 82 units distributed in US and 140 units distributed outside US |
| Distribution | Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Ital |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102422 | SPACELABS MEDICAL PATIENT MONITORS Spacelabs Medical, Inc., Dec 7, 2010 |