DISCOVERY NM/CT 670 TANDEM

Additional Manufacturer Narrative

D4 - NO UDI AVAILABLE AS DEVICE WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE. LEGAL MANUFACTURER: HCS HAIFA FI - 4 HAYOZMA ST. ISRAEL TIRAT HACARMEL HEFA, 30200. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS POTENTIAL MALFUNCTION THAT MAY HAVE BEEN CAUSED BY TRANSPORTATION OR RELOCATION WITHOUT PROPER DETECTOR SUPPORT, PER 21 CFR 806 ON 18-DEC-2024. THE FDA RECALL NUMBERS ARE Z-0888-2025, Z-0889-2025, Z-0890-2025, Z-0891-2025, Z-0892-2025, Z-0893-2025, Z-08894-2025, Z-0895-2025, Z-0896-2025, Z-0897-2025, Z-0898-2025, Z-0899-2025 & Z-0900-2025. CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND INSTRUCTIONS TO STOP USING THE AFFECTED UNITS. GEHC WILL CORRECT ALL AFFECTED UNITS PER THE FIELD MODIFICATION INSTRUCTIONS.

Description of Event or Problem

AS PART OF A FIELD MODIFICATION ACTION FOR POTENTIAL DETECTOR MOUNTING MECHANISM DAMAGE, POTENTIALLY IMPACTED DEVICES IN THE FIELD WERE INSPECTED. DURING THE INSPECTION, THIS UNIT WAS CONFIRMED TO HAVE THE ISSUE WITH THE DETECTOR MOUNTING MECHANISM, AND THE UNIT WILL BE CORRECTED AT THE SITE. THIS ISSUE MAY HAVE BEEN CAUSED BY IMPROPER SUPPORT DURING A SYSTEM RELOCATION, RESULTING IN EXCESSIVE FORCE BEING APPLIED TO THE DETECTOR MOUNTING MECHANISM. THE ISSUE WAS IDENTIFIED AND WILL BE CORRECTED AS PART OF THE CORRECTION AND REMOVAL INITIATED BY GE HEALTHCARE (GEHC) ON 18-DEC-2024 (Z-0888-2025, Z-0889-2025, Z-0890-2025, Z-0891-2025, Z-0892-2025, Z-0893-2025, Z-08894-2025, Z-0895-2025, Z-0896-2025, Z-0897-2025, Z-0898-2025, Z-0899-2025 & Z-0900-2025). THERE WAS NO INCIDENT (NO DETECTOR FALL) AND NO PATIENT INVOLVEMENT.