Z-0538-04

Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00

Name: Z-0538-04 Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
Creator: Welch Allyn Protocol, Inc
Published: 2003-12-31
License: https://open.fda.gov/license/

Welch Allyn Protocol, Inc. / initiated 2003-12-31 / Terminated

FDA source

Welch Allyn Protocol, Inc began a recall of Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00 on 2003-12-31. The reason FDA records is "Potential failure to audibly alarm due to speaker hardware component failure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0538-04
Status: Terminated
Initiated: 2003-12-31
Posted: 2004-02-13
Terminated: 2005-01-06
Recalling firm: Welch Allyn Protocol, Inc.
Product: Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
Product code: DSI Detector And Alarm, Arrhythmia
Reason for recall: Potential failure to audibly alarm due to speaker hardware component failure.
FDA root cause: Other
Action: The firm sent a letter dated December 31, 2003 instructing their customers to install an audio cable from the CPU to the Flat Panel Monitor to provide redundant speaker capability. The audio cable and installation instructions were included in the letter. The letter also included a Correction Response Form which customers should fill out upon completion of correction.
Quantity in commerce: 233 devices
Distribution: The firm distributes the product nationwide and internationally.
Product codes and lots: CPU Serial Numbers: LT00001-LT000015, LT000017-LT000019, TA00274, TA00415, TA00415-HA, TA00468, TA00554, TA00582, TA 00587, TA00587-HA, TA00639, TA00738, TA00745, TA00854, TA00856, TA00861, TA00880, TA00889, TA00891, TA01200, TA01217, TA01218, TA01253, TA01278, TA01279, TA01286, TA01304, TA01306, TA01327, TA01359, TA01359-HA, TA01387, TA01387-HA, TA01388-TA01398, TA01391HA, TA01400-TA01411, TA01413-TA01423, TA01426-TA01435, TA01433-HA, TA01438--TA01446, TA01448-TA01455, TA01453-HA, TA01457-TA01461, TA01463, TA01463-HA, TA01464, TA01466-TA01469, TA01471-TA01480, TA01473-HA, TA01478-HA, TA01481-HA, TA01482-TA01486, TA01484-HA, TA01485-HA, TA01488, TA01488-HA, TA01490-TA01493, TA01493-HA, TA01499-TA01515, TA01508-HA, TA01509-HA, TA01510-HA, TA01515-HA, TA01517-TA01526, TA01522-HA, TA01523-HA, TA01525-TA01528, TA01530-TA01546, TA01534-HA, TA01535-HA, TA01536-HA, TA01537-HA, TA01544-HA, TA01548-TA01550, TA01552--TA01561, TA01561-HA, TA01563-TA01570, TA01567-HA, TA01568-HA, TA01574.

Product code DSI

K022453Class IIModification to Acuity Central Monitoring SystemWelch Allyn Protocol, Inc. / cleared 2002-08-21

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)