Corpuls 3 Defib Including Accessories And Upgrades

Corpuls 3 Defibrillator Recall Summary GS Elektromedizinische GmbH is recalling Corpuls 3 defibrillators and their accessories in New Zealand because the software requires an upgrade. The recall affects hospitals, pharmacies, and laboratories that have this equipment. This is classified as a Class I recall, the most serious type.

Recalling firm
Universal Specialities Ltd trading as USL Medical
Product
Corpuls 3 Defib including Accessories and Upgrades. [Device]. Model: Corpuls 3 / Corpuls 3 Touch. Affected: Software versions SW-REL-4.3.3, 4.4.2, or 4.4.3
Reason
In corpuls3 modules running software versions SW-REL-4.3.3, 4.4.2, or 4.4.3 in combination with a license for automatic ECG interpretation (Glasgow Full Scale or HES), an internal configuration file may, in very rare cases, be lost during the boot process. This behaviour occurs randomly and cannot be influenced by the user., If this condition occurs, the functions for automatic ECG interpretation and the specific ECG alarms (corpuls ACS) are not available. The basic device functions for ECG signal acquisition and display remain available. The alarm message Possible acute STEMI also remains...
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-03-30
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/cb5faa8e-a8c9-424c-93af-2985193c54ce