[Recalled] GE Optional Laser Centering Device X-ray generator. — GE has identified a potential failure to comply with 21 C.F.R | FDA 2014-11-10
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | GE Optional Laser Centering Device X-ray generator. |
|---|---|
| Brand / manufacturer | GE Inspection Technologies, LP |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2320-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 November 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: GE has identified a potential failure to comply with 21 C.F.R. ¿ 1040.10 and 21 C.F.R. ¿ 1010.2 for the alignment laser centering device.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from GE Inspection Technologies, LP
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.