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Terminated

WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

FDA Recall Z-1855-2021 · Posted None

Recalling FirmAbbott Laboratories Inc. (St Jude Medical)
Recall StatusTerminated
Product CodeDQK
Date Initiated2021-05-05
Date Terminated2024-06-18
Product Quantity8 units

Reason for Recall

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

Firm Action

Beginning on May 5, 2021, consignees will be notified in person by an Abbott field representative. The letter explained the issue and provided recommendations to reduce the risk to the patient.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

US Nationwide distribution in the states of MI, KS, MO, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210392WorkMate Claris SystemAbbott · 2021-03-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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