Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Reported: September 19, 2012 Initiated: July 10, 2012 #Z-2255-2012
Product Description
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Reason for Recall
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 254 total in the US
- Distribution
- Worldwide Distribution -- USA (nationwide) Distribution
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.. Recalled by GE Healthcare, LLC. Units affected: 254 total in the US.
Why was this product recalled? ▼
Software issue: a violation of 21 CFR 1020.31(a). After an image is taken, when the user selects and clears an additionally displayed screen the system inhibit is also cleared, allowing the user to take an exposure without the technique factors being displayed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2012. Severity: Moderate. Recall number: Z-2255-2012.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11