Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display Recalled by Abbott Laboratories Inc. (St Jude Medical) Due to Due to a software error, the user may...

Date: May 5, 2021
Company: Abbott Laboratories Inc. (St Jude Medical)
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Laboratories Inc. (St Jude Medical) directly.

Affected Products

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 intracardiac signals during cardiac EP studies.

Quantity: 9 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Laboratories Inc. (St Jude Medical)

Abbott Laboratories Inc. (St Jude Medical) has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report