Devices

Device Recall PRIMEVIEW 3i System 2.1

Model / Serial
Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1 Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Class II Recall - Product distribution information pending from firm.
Product Description
Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
Manufacturer
Siemens Medical Solutions USA, Inc
1 Event
- Recall of Device Recall PRIMEVIEW 3i System 2.1

Manufacturer

Siemens Medical Solutions USA, Inc

Manufacturer Address
Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
Source
USFDA

One device with a similar name

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Device Recall PRIMEVIEW 3i System 2.1

Model / Serial
Serial numbers associated with RTT2.0 and RTT2.1
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution
Product Description
PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147675 || Medical charged-particle radiation therapy system.
Manufacturer
Siemens Medical Solutions USA, Inc

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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