Hill-Rom TotalCare Bed Systems Recalled for Alarm Malfunction
Hill-Rom is recalling TotalCare Bed Systems because the exit alarm may fail if armed for over 72 hours without triggering.
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 where a safety feature (exit alarm) may fail, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Hill-Rom, Inc. is recalling TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900, along with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A. The recall involves 3,037 units distributed in the United States and several international countries, including Australia, Canada, and Germany.
The recall is issued because the bed exit alarm may not function properly if it has been armed for a period longer than 72 hours without being triggered by patient movement or the removal of patient weight. This malfunction could result in the alarm failing to sound when a patient attempts to exit the bed.
Healthcare facilities and consumers should contact Hill-Rom, Inc. for instructions on how to address this issue. The source text does not specify a particular consumer action beyond the general recall notice, but users should verify if their specific serial numbers fall within the affected ranges provided in the official recall documentation.
The recalled product
- Product
- TotalCare Bed Systems, Model Numbers P1900, PR1900, and U1900 with 3-Level Patient Position Monitoring and Scale Upgrade Kits, Model Numbers P1947A and P1948A).
- Manufacturer
- Hill-Rom, Inc.
- Category
- Medical Device — Hospital Bed
- Affected units
- 3,037
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)
- 2013 (not serialized).
Distribution
Distributed nationwide across the United States.
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