Hillrom Temperature Management Controllers May Experience Power-On Self-Test Error
Hillrom Temperature Management Controller Model 2083516 may experience a power-on self-test error code 'EA POST' during startup. The recall affects 77 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is an FDA Class II medical device recall involving a power-on self-test error that could affect device function. No illnesses or injuries have been reported, but the error represents a risk-of-harm in a patient-care device.
Plain-English summary
Augustine Temperature Management, LLC is recalling the Hillrom Temperature Management Controller, MP, Model 2083516, a temperature management device used with warming blankets and mattresses. The recall involves 77 units distributed worldwide.
The recalled devices may experience a power-on self-test error code 'EA POST' during startup, which could indicate a device malfunction. Units with UDI-DI 00850011479582 are affected. The complete list of affected serial numbers is available from the manufacturer.
Individuals and healthcare facilities using these devices should verify their device's serial number and contact Augustine Temperature Management, LLC for guidance on remediation or device replacement.
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
- 77
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 (20)
- UDI-DI 00850011479582
- Serial Numbers: 23010166
- 23010167
- 23010168
- 23010169
- 23010170
- 23010171
- 23010172
- 23010173
- 23010174
- 23010175
- 23010176
- 23010177
- 23010178
- 23010179
- 23010180
- 23010181
- 23010182
- 23010183
- 23010184
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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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