FDAClass IIMay 8, 2019

Nm/ct 870 CZT recall

NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging…

Why was Nm/ct 870 CZT recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Mfg. Lot or Serial # System ID 87CY63017 SHIPPED (AO 1630621) 87CX63007 AH0101NM05 87CX63014 030078NU28 87CX63008 190020NU01 87CX63006 030240NU11 87CX63015 705743NM870 87CX63011 M4184879 87CX63003 M9886873 87CX63004 X171582003 87CX63009 M171582018 87CX63010 UC1796NU01 87CX63013 NO1068MN18 87CX63005 A004NU20 87CX63002 C028NU01 87CX63012 C028NU02 87CX63001 900010NU12

Product
NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging…
Recalling firm
GE Healthcare, LLC
Quantity
16 units
Distribution
US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
Recall date
May 8, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls