Hillrom Temperature Management Controller Power-On Self-Test Error Code Update
Augustine Temperature Management recalled Hillrom Temperature Management Controllers (Models WC71, WC77, and MP 2083516) due to power-on self-test error code EA POST. No injuries or illnesses reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a temperature management controller, which is a risk-of-harm product. While no illnesses or injuries have been reported, malfunction indicated by the self-test error could potentially result in improper temperature control.
Plain-English summary
Augustine Temperature Management has issued a recall of Hillrom Temperature Management Controllers, Models WC71, WC77, and MP Model 2083516, used in conjunction with warming blankets and mattresses. Approximately 116 units distributed in the United States and Canada are affected, identified by UDI-DI 00850011479582 and serial numbers 22120000 through 24030030.
The recall addresses a power-on self-test error code, EA POST, that appears when the device is powered on. An instructions for use update has been issued by the manufacturer to address this error code.
Users of affected devices should review the updated instructions for use provided by Augustine Temperature Management regarding proper response to the EA POST error code.
The recalled product
- Product
- Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
- Manufacturer
- Augustine Temperature Management, LLC
- Affected units
- 116
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI 00850011479582
- Serial Numbers: 22120000-24030030
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Augustine Temperature Management, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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