Hill-Rom Recalls NaviCare Patient Safety Software Due to Bed Exit Mechanism Failure
Hill-Rom Inc. is recalling NaviCare Patient Safety Software versions 3.5.400-3.9.300 because a software issue may cause the patient bed exit mechanism to fail to monitor or control.
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: The recall involves a medical device with a defect that poses a risk of harm to patients (failure to control bed exit mechanism), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hill-Rom Inc. is recalling 35 systems of NaviCare Patient Safety Software, versions 3.5.400 through 3.9.300. The software is compatible with specific Hill-Rom hospital beds, including VersaCare, Centrella, and Progressa models.
The recall is due to a software issue that may result in the failure to monitor or control the patient's bed exit mechanism. This defect could potentially compromise patient safety by allowing unintended movement or exit from the bed.
The affected software systems were distributed in Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, and Washington. Healthcare facilities using these specific software versions should contact Hill-Rom Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety (Patient Safety) Software is compatible with the following beds: 1. VersaCare Revision A-J with upgrade kit Revision K with UCB 1.18 2. Centrella (all versions) 3. Progressa…
- Manufacturer
- Hill-Rom Inc.
- Affected units
- 35
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 (1)
- NaviCare Patient Safety Software versions 3.5.400 to 3.9.300
Distribution
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