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Recall Observatory FDA recall evidence

Device product

NM/CT 850 Model Number: H3907AD

Z-2991-2020

August 14, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 86337
Status
Terminated
Classification
Class II
Quantity
25 units
Official record key
device-enforcement:Z-2991-2020

Official wording

Reason: Rotor bearing screws were found loose on detector.

Code information: Serial # 85EX67001 System ID: 203789NM850 Serial # 85EX67023 System ID: 813443D850 Serial # 850X61005 System ID: 847618NM850 Serial # 85EX67019 System ID: 773296NM850 Serial # 85EX67021 System ID: 217554NMCT Serial # 85EX67008 System ID: 779696NM850 Serial # 85EY67015 System ID: 504988NM850 Serial # 85EX67017 System ID: 318212NM Serial # 85EX67012 System ID: 781729NM Serial # 85EX67006 System ID: 573814NM2 Serial # 850X61001 System ID: Not Available Serial # 85EX67002 System ID: 419289D850 Serial # 85EX67009 System ID: 513732NM Serial # 85EX67016 System ID: 972969NM Serial # 85EX67004 System ID: 571472NM850 Serial # 85EX67010 System ID: 804289NM850A Serial # 85EX67011 System ID: 804281NM850A Serial # 85EX67005 System ID: 715717NMCT Serial # 85EX67018 System ID: 414219NMCT Serial # 85EX67013 System ID: 920456NM Serial # 850X61004 System ID: 030601NU06 Serial # 85EX67007 System ID: A5116074 Serial # 850X61002 System ID: NS0001 Serial # 85EX67003 System ID: PL1692NM05 Serial # 85EX67014 System ID: PPR59076

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Rotor bearing screws were found loose on detector.