Recall Z-1056-2023— GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Name: FDA recall Z-1056-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-19

Class I · Ongoing

Class I FDA medical device recall by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING, initiated 2022-12-19. It names one FDA 510(k) clearance: K121019. Product: GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System. Reason: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury..

Recalling firm: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Classification: Class I
Status: Ongoing
Initiated: 2022-12-19
Firm location: Tirat Carmel, Israel

510(k) clearances named in this recall

1 on FDA's record

K121019 — OPTIMA NM/CT 640GE Healthcare·cleared 2012-04-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System

Reason for recall

A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.

Data sourced from openFDA. This site is unofficial and independent of the FDA.