Z-1333-04

Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00

Name: Z-1333-04 Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
Creator: Welch Allyn Protocol, Inc
Published: 2004-06-08
License: https://open.fda.gov/license/

Welch Allyn Protocol, Inc. / initiated 2004-06-08 / Terminated

FDA source

Welch Allyn Protocol, Inc began a recall of Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00 on 2004-06-08. The reason FDA records is "Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1333-04
Status: Terminated
Initiated: 2004-06-08
Posted: 2004-08-10
Terminated: 2006-06-21
Recalling firm: Welch Allyn Protocol, Inc.
Product: Welch Allyn Vital Signs Monitor 5300 Series 300 Part numbers 007-0098-00 through 007-0159-00
Product code: DQA Oximeter
Reason for recall: Potential speaker failure could result in absence of audible annunciation of pulse tones, patient alarms and equipment alerts.
FDA 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 in commerce: 1828 units
Distribution: Welch Allyn distributes product to hospitals, physicians and distributors nationwide and internationally.
Product codes and lots: Serial numbers JA000225 through JA002052.

Product code DQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)