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Recall Observatory FDA recall evidence

Device product

NM/CT 860, SPECT/CT

Z-2992-2020

August 14, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 86337
Status
Terminated
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-2992-2020

Official wording

Reason: Rotor bearing screws were found loose on detector.

Code information: Serial # 850X61003 , System ID: 401793860NM, Model # H3908AD Serial # 860X62001 , System ID:E6843969, Model # H3908AE Serial # 870X64005 , System ID:HC4387NU05, Model # H3100AS Serial # 860X62002 , System ID:PL0399NM01, Model # H3100AS

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.