Recall Z-3032-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Llc
Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, & 91393 are sold with with Perioperative Mode (option D), which includes Start case/End case functionality. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Heal
| Date | Aug 17, 2011 (initiated Jul 8, 2011) |
| 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. |
| Root cause | Device Design |
| Action | Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated July 25, 2011 along with the Perioperative section of the Operations Manual to all consignees in the US. This letter includes recalled model 91369, 91370, 91387, & 91393 (option D). On July 27, 2011, Spacelabs sent out an updated recall notification letter to include one additional model 91367 to all consignees in the US. The letter identifies the products, problem, and actions to be taken. On August 2, 2011, a recall notification letter (translated as necessary) and the Perioperative section of the Operations Manual was em |
| Quantity | total 2812 units distributed worldwide |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, Bahrain, Bolivia, Brazil, Canada, Caymen Island, Chile, China, Colombia, Cyprus, Ecuador, Finland, France, Germany, Guam, India, Indonesia, Israel, Italy, Jordan, Mexico, Morocco, New Zealand, Nicaragua, Pakistan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102422 | SPACELABS MEDICAL PATIENT MONITORS Spacelabs Medical, Inc., Dec 7, 2010 |