The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1854-2021·Announced 2021-06-23

Cardiac Monitoring System Software Error May Disable Device

Abbott's WorkMate Claris cardiac monitoring system (Model H700124) is being recalled due to a software error that may disable the system or turn the screen black. Nine units affected in Michigan, Kansas, Missouri, and Texas.

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 an FDA Class II recall for a software error in a cardiac monitoring system. Although no injuries have been reported, the loss of functionality or black screen during operation represents a risk of harm for a system designed to monitor cardiac signals during medical procedures, justifying High severity classification.

Plain-English summary

Abbott Laboratories Inc. (St Jude Medical) is recalling the WorkMate Claris System Display, Model H700124, with v.1.2 Upgrade Kit or v.1.2 software upgrade installed. The WorkMate Claris System is a computer-based electrocardiographic recording and monitoring system used during cardiac electrophysiology studies to capture, display, and retrieve surface and intracardiac electrical signals.

A software error in the v.1.2 upgrade can cause users to lose access to system functionality or experience a complete black screen during operation. This malfunction could prevent proper monitoring and recording of cardiac signals during cardiac electrophysiology procedures.

Nine units have been identified with this issue and are distributed across Michigan, Kansas, Missouri, and Texas. The affected serial numbers are: 14774202, 14779111, 15812169, 15812170, 18243196, 18243205, 18643643, 18782716, and 18917926. Users of this system should verify their serial number and contact Abbott/St Jude Medical for instructions on obtaining a corrected software version or replacement unit.

The recalled product

Product
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a computer-based electrocardiographic recording and monitoring system designed for efficient capture, display, and retrieval of surface and…
Manufacturer
Abbott Laboratories Inc. (St Jude Medical)
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
9

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 (9)

  • Serial Numbers: 14774202
  • 14779111
  • 15812169
  • 15812170
  • 18243196
  • 18243205
  • 18643643
  • 18782716
  • 18917926

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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