Welch Allyn Protocol, Inc Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
Brand
Welch Allyn Protocol, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Welch Allyn Protocol, Inc is recalling Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00 due to Potential failure to audibly alarm due to speaker hardware component failure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential failure to audibly alarm due to speaker hardware component failure.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026