GE Medical Systems, LLC recalls Optima XR646 HD. X-Ray imaging system.
The user can continue to take the next exposure after reaching the Automatic Exposure Control (AEC) limit, without taking any further actions to acknowledge or adjust exposure techniques. In all cases, a message still…
Read the official notice →- Date
- 2025-02-12
- Country
- United States
- Brand
- GE Medical Systems
- Product
- Optima XR646 HD. X-Ray imaging system.
- Classification
- Class II
- Units
- Worldwide Distribution: US (nationwide) including Puerto Rico and OUS…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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