Urgent Field Safety Notice For Case Cardiac Testing System By Ge Medical Systems Information Technologies, Inc.

Recall Summary GE Medical Systems Information Technologies, Inc. is issuing an urgent field safety notice for the CASE Cardiac Testing System. The recall is classified as Class I, the most serious level. The affected systems were distributed in Germany and the EU.

Recalling firm

Urgent Field Safety Notice for CASE Cardiac Testing System by GE Medical Systems Information Technologies, Inc. , Downlo

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for CASE Cardiac Testing System by GE Medical Systems Information Technologies, Inc

Reason

assessment Field corrective actions Urgent Field Safety Notice for CASE Cardiac Testing System by GE Medical Systems Information Technologies, Inc

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-05-28

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/2051c804-eadd-407f-9086-4b056a9d9a5e