Terminated

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. The monitor provides programmable audible and visual alarms and automatic NIBP measurements at selectable intervals.

FDA Recall Z-1873-2009 · Posted 2009-07-30

Recalling FirmWelch Allyn Protocol, Inc

Recall StatusTerminated

Product CodeMWI

Date Initiated2009-07-28

Date Terminated2011-08-10

Product Quantity68,123

Reason for Recall

The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms.

Firm 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 Services. Direct questions about this recall to Welch Allyn Protocol, Inc. by calling 1-503-530-7935.

Root Cause

Device Design

Distribution Pattern

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, Jordan, Kenya, Kyrgyzstan, South Korea, Kuwait, Lebanon, Sri Lanka, Malaysia, Nigeria, The Netherlands, Norway, New Zealand, Oman, Phillipines, Pakistan, Poland, Puerto Rico, Panama, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Thailand, Taiwan and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063419MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )Welch Allyn Protocol, Inc. · 2006-12-04 K053027VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)Welch Allyn, Inc. · 2005-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.