The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1262-2019·Announced 2019-05-08

GE Healthcare Recalls NM/CT 850 Systems Due to Detector Screw Issue

GE Healthcare is recalling 31 NM/CT 850 systems because detector screws may not have been secured correctly, potentially compromising mounting redundancy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that could lead to the loss of mounting redundancy, representing a risk of harm where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling 31 units of the NM/CT 850 system. This medical device is intended for general Nuclear Medicine imaging procedures and includes a Computed Tomography component for attenuation correction and anatomical localization.

The recall was initiated because, during installation of certain systems delivered with dismounted detectors, some detector screws may not have been secured correctly. This defect leads to the possible loss of one detector mounting design redundancy.

The affected units were distributed in the US and in Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, and the UK. Specific serial numbers and system IDs for the affected units are listed in the agency's recall record.

The recalled product

Product
NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by…
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Imaging Equipment
Hazard
Affected units
31

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Mfg. Lot or Serial # System ID Model

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 10 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · structural defect

See all →

Similar recalls