FDAJuly 24, 2017device
Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are at high risk of sudde...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac ResynchronizationTherapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.
What to do
FDA enforcement status: Terminated
Brands named
sorin group italia srl crfsorinsorin group
UPCs
08031527015477
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCZMC Group Recalls Multiple Light Up Toys Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys2026-05-07
- FDACANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, Net wt. 240g 8.47 oz UPC: 8056093851380 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)2026-05-06
- FDA.155 CRUNCHY CANNOLI GLUTEN FREE intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, 190g 6.70 oz - 20 packages per case LOT: 2523000012 - BEST BEFORE: 10/17/2026 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)2026-05-06
- CPSCCBC Group Recalls Stephan Baby Boo Bunnie and Friends Children's Toys Due to Risk of Serious Injury from Choking and Laceration Hazards2026-04-30
- CPSCZMC Group Recalls LED Finger Beam Lights Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys2026-04-16
- 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
- FDA1ml of DTT in liquid phase, in PET tube with capture cap, in bulk2025-10-29
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