Device Recall Primeview 3i

Serial Numbers: 10007, 10021, and 10014

Radiology Devices

2

No

Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.

Siemens Primeview 3i 2.0 medical charged-particle radiation therapy system, Part No: 8139487, with software version 3i 2.0. Siemens AG, Concord, CA.

Serial Numbers: 3764, 10003, 10014, 10017, 10020, 10005, 10007, 10008, 10010, 10011, 10013, 10028, 10001, 10006, 10022, 10026, 10033, 10002, 10018, 10019, 10021, 10023, 10024, 10025, 10032, 10048

Radiology Devices

2

No

Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.

Siemens Primeview 3i 2.1 medical charged-particle radiation therapy system, Part No: 8147675, with software version 3i. Siemens AG, Concord, CA.

Serial numbers associated with RTT2.0 and RTT2.1

Radiology Devices

Worldwide Distribution

PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139847 || Medical charged-particle radiation therapy system.

Serial numbers associated with RTT2.0 and RTT2.1

Radiology Devices

2

No

Worldwide Distribution

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.

Serial numbers associated with RTT2.0 and RTT2.1

Radiology Devices

2

No

Worldwide Distribution

PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341428 || Medical charged-particle radiation therapy system.