FDAOctober 28, 2021device
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).
What to do
FDA enforcement status: Ongoing
Brands named
palodex group oypalodexpalodex group
UPCs
064300358727250643003587273206430035872749064300358727560643003587276306430035872770
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- CPSCElectrolux Group Recalls Frigidaire Gas Ranges Due to Burn Hazard2026-03-19
- CPSCModera Recalls Modera Pack N Play Mattresses Due to Risk of Serious Injury or Death from Entrapment; Violates Mandatory Standard for Crib Mattresses2025-10-30
- FDAMajor ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)003090471326142025-09-12
- FDAMajor ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61, UPC (01)003090471316172025-09-12
- FDAMajor ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61, UPC (01)00309047133611 NDC 0904-7133-612025-09-12
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