FDAJune 20, 2020device

Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - Product Usage: intended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including hea...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.

What to do

FDA enforcement status: Ongoing

Brands named

shanghai united imaging healthcareshanghaishanghai united

UPCs

06971576831036

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

FDAChlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-0...2026-06-05
FDAGreat Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase. All affected product ...2026-05-15
FDASalt2026-05-14
FDASiemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay2026-05-07
CPSCBayer Recalls 6 mL Size Afrin Original Nasal Spray Bottles Due to Risk of Serious Injury or Illness from Child Poisoning; Violates Mandatory Standard for Child-Resistant Packaging2026-04-30
FDABrand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.2026-04-22
FDAepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;2026-04-02
FDABrand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic para...2026-03-26

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