Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
This recall has been terminated (originally issued August 10, 2004).
- Company
- Welch Allyn Protocol, Inc
- Recall Initiated
- June 8, 2004
- Posted
- August 10, 2004
- Terminated
- June 21, 2006
- Recall Number
- Z-1333-04
- Quantity
- 1828 units
- Firm Location
- Beaverton, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
Distribution
Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.
Lot / Code Info
Serial numbers JA000225 through JA002052.
Root Cause
Other
Action Taken
The firm contacted their customers and their distributors customers via letters dated June 8, 2004 through July 9, 2004. The letters instruct their customers to verify speaker functionality. If the customers do not hear two quick beeps or there is static then they have a faulty speaker. The letters instruct them to stop using the monitor and contact Welch Allyn to have the monitor repaired. If the monitor continues to emit two quick beeps their customers are to contact Welch Allyn to have the monitor repaired as soon as it is convenient. The customers are to verify the two beeps prior to each use. The letter dated June 8, 2004 went to only a couple of direct customers. The remaining letters dated June 14, 2004, June 23, 2004, June 30, 2004 and July 9, 2004 went to direct customers, distributors and distributors'' end user customers.