Recall – Patient Safety application software error

Company: Hill-Rom Inc.
Date of Enforcement Report: 4/1/2020
Class II

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 (firmware version 1.15.0.0)

  • Recall Number: Z-1554-2020

REASON

There is a software issue which may result in failure to monitor or control patient’s bed exit mechanism.

RECALLING FIRM/MANUFACTURER

Hill-Rom Inc. on 2/14/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

35 Software Systems

DISTRIBUTION

US Nationwide

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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