GE Healthcare, LLC NM/CT 850 Model Number: H3907AD Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

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.

Distribution

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