GE Healthcare, LLC NM/CT 860, SPECT/CT Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NM/CT 860, SPECT/CT
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
GE Healthcare, LLC is recalling NM/CT 860, SPECT/CT due to Rotor bearing screws were found loose on detector.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Rotor bearing screws were found loose on detector.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CT, FL, GA, IL, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NY, OH, OK, RI, SC, TN, TX, VT, VA, WA, WI
Page updated: Jan 10, 2026