Recalls / —

—#183464

Product

NM/CT 870 CZT Model # H3906CW

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K153402

Affected lot / code info

Serial # 87CX63007 System ID: AH0101NM05 Serial # 87CX63008 System ID: 190020NU01 Serial # 87CX63006 System ID: 030240NU11 Serial # 87CX63015 System ID: 705743NM870 Serial # 87CX63014 System ID: 030078NU28 Serial # 87CX63011 System ID: M4184879 Serial # 87CX63003 System ID: M9886873 Serial # 87CX63004 System ID: X171582003 Serial # 87CX63009 System ID: M171582018 Serial # 87CX63010 System ID: UC1796NU01 Serial # 87CX63013 System ID: NO1068MN18 Serial # 87CX63005 System ID: A004NU20 Serial # 87CX63002 System ID: C028NU01 Serial # 87CX63012 System ID: C028NU02 Serial # 87CX63001 System ID: 900010NU12

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 #183464. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.