Recalls / —

—#183466

Product

NM 830 Model # H3910AC

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K111445
Affected lot / code info: Serial # 830X60001 System ID: 479338N830 Serial # 830X60004 System ID: 901227NM1 Serial # 830X60018 System ID: 772468NM830 Serial # 830X60012 System ID: 813315D830 Serial # 830X60011 System ID: 225761NM1 Serial # 830X60014 System ID: 225761NM Serial # 830X60016 System ID: 225761NM Serial # 830X60019 System ID: 573458NM Serial # 830X60023 System ID: 718238D830 Serial # 830X60006 System ID: 716862NM830 Serial # 830X60015 System ID: 585396NM Serial # 830X60003 System ID: 585786NM830 Serial # 830X60025 System ID: 405717NM830 Serial # 830X60021 System ID: 615316NM830 Serial # 830X60017 System ID: 956323NM830 Serial # 830X60002 System ID: 100039NU05 Serial # 830X60022 System ID: 705743DNM830 Serial # 830X60024 System ID: 416898NM830 Serial # 830X60013 System ID: M4040557 Serial # 830X60010 System ID: NS0102 Serial # 830X60020 System ID: NS0101 Serial # 830X60009 System ID: 0850260168 Serial # 830X60005 System ID: 0850260165 Serial # 830X60008 System ID: 0850260166 Serial # 830X60007 System ID: 752030NU01

Why it was recalled

Rotor bearing screws were found loose on detector.

Root cause (FDA determination)

Use error

Action the firm took

GE Healthcare issued an Urgent Medical device correction notification on August 14, 2020. It states the following: 1. GE Healthcare will inspect and, if required, correct all affected products at no cost to you. 2. A GE Healthcare representative will contact you to arrange for the correction 3. Please complete the acknowledgement form and return it to GE Healthcare promptly upon receipt and no later than 30 days from receipt to nm.fmi40890.responses@ge.com If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM

Timeline

Recall initiated: 2020-08-14
Terminated: 2021-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.