The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1853-2021·Announced 2021-06-23

WorkMate Claris Cardiac Monitoring System Software Error Causes Loss of Functionality

Abbott's WorkMate Claris cardiac monitoring system may lose functionality or display a black screen during operation due to a software error affecting 4 distributed units.

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: This is a Class II medical device with a software defect affecting critical cardiac monitoring functionality. However, the recall notice does not report any illnesses, injuries, or deaths, placing it in the High severity category as a risk-of-harm medical device without reported patient harm.

Plain-English summary

The WorkMate Claris System, Model H700123, is an electrocardiographic recording and monitoring device used during cardiac electrophysiology studies to capture, display, and retrieve surface and intracardiac signals. This recall involves the v.1.2 upgrade kit or systems with the v.1.2 upgrade already installed.

A software error in the v.1.2 upgrade can cause users to lose system functionality or encounter a black screen during operation. This defect may prevent proper monitoring and signal retrieval during cardiac procedures.

Four units with the affected upgrade were distributed across Michigan, Kansas, Missouri, and Texas. The specific serial numbers involved are 14399319, 15508962, 18782712, and 18855856.

The recalled product

Product
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris System, Model H700123. The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and intracardiac signals…
Manufacturer
Abbott Laboratories Inc. (St Jude Medical)
Category
Medical Device — Cardiac Monitoring System
Hazard
Affected units
4

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 (4)

  • Serial Numbers: 14399319
  • 15508962
  • 18782712
  • 18855856

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Abbott Laboratories Inc. (St Jude Medical) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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