Z-1554-2020 Class II Terminated
FDA device recall Z-1554-2020 was initiated by Hill-Rom Inc. on February 14, 2020 and is designated Class II. Reason for recall: There is a software issue which may result in failure to monitor or control patient's bed exit mechanism. The recall status is terminated (terminated February 11, 2021). Affected quantity: 35 Software Systems.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- February 14, 2020
- Termination Date
- February 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 Software Systems
Product Description
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 (firmware version 1.15.0.0)
Reason for Recall
There is a software issue which may result in failure to monitor or control patient's bed exit mechanism.
Distribution Pattern
Colorado, Georgia, Indiana, Louisiana, North Carolina, Nevada, Oregon, South Carolina, Tennessee, Virginia, Washington.
Code Information
NaviCare Patient Safety Software versions 3.5.400 to 3.9.300