GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-2992-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

NM/CT 860, SPECT/CT

Product Classification:

Class II

Date Initiated: August 14, 2020

Date Posted: September 30, 2020

Recall Number: Z-2992-2020

Event ID: 86337

Reason for Recall:

Rotor bearing screws were found loose on detector.

Status: Terminated

Product Quantity: 4 units

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

Voluntary or Mandated:

Voluntary: Firm initiated