Welch Allyn Acuity Central Monitoring Station (With SunBlade Model 150,650 MHZ. Part # 700-0362-00
This recall has been terminated (originally issued February 13, 2004).
- Company
- Welch Allyn Protocol, Inc
- Recall Initiated
- December 31, 2003
- Posted
- February 13, 2004
- Terminated
- January 6, 2005
- Recall Number
- Z-0538-04
- Quantity
- 233 devices
- Firm Location
- Beaverton, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Potential failure to audibly alarm due to speaker hardware component failure.
Distribution
The firm distributes the product nationwide and internationally.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.