FDA Medical Device Recalls (openFDA)
Welch Allyn Protocol, Inc: Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
- Recall number
- Z-1333-04
- Recalling firm
- Welch Allyn Protocol, Inc
- Product
- Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
- Status
- Terminated
- Initiated
- 2004-06-08
- Posted
- 2004-08-10
- Terminated
- 2006-06-21
- Reason
- Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
- Root cause
- Other
- Action
- 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.
- Quantity
- 1828 units
- Distribution
- Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.
- Lot, serial or model codes
- Serial numbers JA000225 through JA002052.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQA
- Firm FEI
- 3023750
- Firm city
- Beaverton
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28