Recall Z-1873-2009 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Welch Allyn Protocol, Inc
Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasive blood pressure (NIBP), pulse rate, and mean arterial pressure (MAP). Units configured with the appropriate options can also simultaneously monitor temperature and noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and continuously monitor pulse rate. Th
| Date | Jul 30, 2009 (initiated Jul 28, 2009) |
| Status | Terminated |
| Reason | The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms. |
| Root cause | Device Design |
| Action | An "Urgent: Correction" letter dated July 28, 2009 was sent to customers describing the risk associated with loss of audible alarms and recommend that the users mitigate the risk by checking for proper audible alarm function each time they power on the device. (Current labeling describes the variety of beeps and tones that should be present). Users were instructed: 1) if the audio fails, do not use the device, 2) Remove it from service and 3) contact Welch Allyn Protocol, Inc. at the following telephone number (1-800-289-2501) to arrange the return and repair of your device to Technical Se |
| Quantity | 68,123 |
| Distribution | Worldwide Distribution -- US, United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Bulgaria, Bahrain, Botswana, Canada, Switzerland, China, Cyprus, Germany, Denmark, Egypt, Spain, Figi, France, Great Britain, Greece, Hong Kong, Croatia, Indonesia, Ireland, Israel, India, Iceland, Italy, J |
| FDA record | Open on fda.gov |