Reported Nov 19, 2014 · Terminated
Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
Optima NM/CT 640Models H3100YAH3100YC
- Product UsageThe GE Optima NM/CT 640 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 (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
- Lot codes and dates
25018816234D64026004815564O64026007817250NM64026010717782640NM26012808485NM64026013847872O64026014901516GO64026018270956NM64026020309672NM226021215728OPT64026025410543NUC64026026928214NMCT26028715735OPT126002091026325626005091026325322020030232NU1526009DK1054NM0326001XM20340126003ULUE01NU0226015915839NU012602408302680000811326006A563961326008A536630825023RTD078226030NM2603026023BD003NU012601700162NUC112601900203NUC062602200139NUC08
- Amount recalled
- 29
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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