Z-1262-2019 Class II Terminated
FDA device recall Z-1262-2019 was initiated by GE Healthcare, LLC on March 20, 2019 and is designated Class II. Reason for recall: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector moun… The recall status is terminated (terminated October 5, 2020). Affected quantity: 31 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2019
- Initiation Date
- March 20, 2019
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 units
Product Description
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 various acquisition types, and a Computed Tomography component which is intended specifically for enabling attenuation correction and anatomical localization of SPECT images.
Reason for Recall
During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.
Distribution Pattern
US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Code Information
Mfg. Lot or Serial # System ID Model, Catalogue or Code # 85EX67018 4740081NM11 H3907AD 85EX67001 203789NM850 H3907AD 850X61005 319768NMCT H3907AD 850Y61006 319768NMH988 H3907AD 85EX67022 847618NM H3907AD 85EX67019 773975NMCT H3907AD 85EX67008 779696NM850 H3907AD 85EX67017 318212NM H3907AD 85EX67012 781729NM H3907AD 85EX67015 SHIPPED (AO 1623723) H3907AD 85EX67020 SHIPPED (GON 4745963) H3907AD 85EX67023 SHIPPED (GON 4704278) H3907AD 85EX67024 SHIPPED (GON 4710759) H3907AD 85EY67025 SHIPPED (AO 1638499) H3907AD 85EY67026 SHIPPED (AO 1638498) H3907AD 85EY67028 SHIPPED (AO 1638502) H3907AD 85EX67009 513732NM 5782013 85EX67002 419289D850 H3907AD 85EX67016 972969NM H3907AD 85EX67004 571472NM850 H3907AD 85EX67021 SHIPPED (GON 4640067) H3907AD 85EX67010 804289NM850A H3907AD 85EX67011 804281NM850A H3907AD 85EX67005 715717NMCT H3907AD 85EX67013 920456NM H3907AD 850X61004 030601NU06 H3907AD 850X61002 NS0001 H3907AD NT3BG1900001BH NS0401 5376204-50-1 85EX67003 PL1692NM05 H3907AD 85EX67014 PPR59076 H3907AD 850Y61007 SK1082NM02 H3907AD