Welch Allyn Vital Sign Monitor 5300 Series/Class II. (VSM 300). The VSM300 can monitor systolic and diastolic noninvasiv
FDA device recall Z-1873-2009 · posted 2009-07-30 · Terminated
Recall details
- Recalling firm
- Welch Allyn Protocol, Inc
- Reason for recall
- The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.
- Action taken
- 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 Services. Direct questions about this recall to Welch Allyn Protocol, Inc. by calling 1-503-530-7935.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 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, Fra
- Date initiated
- 2009-07-28
- Date posted
- 2009-07-30
- Date terminated
- 2011-08-10
- Location
- Beaverton, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) (K063419) | Welch Allyn Protocol, Inc. | 2006-12-04 |
| VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) (K053027) | Welch Allyn, Inc. | 2005-11-22 |