Recall – Fluid control system displays incorrect deficit

Company: WOM World of Medicine AG
Date of Enforcement Report: 10/9/2019
Class II

PRODUCT

Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

  • Recall Number: Z-2767-2019

REASON

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

RECALLING FIRM/MANUFACTURER

WOM World of Medicine AG on 8/14/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

322 units

DISTRIBUTION

US Nationwide

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.