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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 15 Results
PMA Number: P980049
 
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Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defib... 2 Sep-28-2017 Sorin Group Italia SRL - CRF
Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrill... 2 Sep-28-2017 Sorin Group Italia SRL - CRF
Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrill... 2 Sep-28-2017 Sorin Group Italia SRL - CRF
Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defib... 2 Sep-28-2017 Sorin Group Italia SRL - CRF
INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARAD... 2 May-18-2017 Sorin Group Italia SRL - CRF
PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT-D 9750, SonR 8770, RF ... 2 May-18-2017 Sorin Group Italia SRL - CRF
OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 6250, OVATIO DR 6550, PARA... 2 May-18-2017 Sorin Group Italia SRL - CRF
The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and i... 2 Nov-15-2016 Sorin Group USA, Inc.
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program ... 2 Nov-15-2016 Sorin Group USA, Inc.
ORCHESTRA/ORCHESTRA PLUS Programmer 2 Jan-22-2014 Sorin Group Italia S.r.l.
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