FDA (Devices) recall action 64675

Siemens Medical Solutions USA, Inc recalled 9 products on 2013-04-10

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2013-04-10
Critical: 0
Units: 5,589

Why these products were recalled

Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–9 of 9

ModerateFDA (Devices)··2013-04-10
Siemens COHERENCE RT Therapist Software Recalled for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.0, Part No. 8139839, Current R630; Product Usage: The intended us
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Safety Defects
Siemens is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions to address performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE Impression TH, Part No. 7341410, Current R630; Product Usage: The intend
Category
Distribution
0 states
HighFDA (Devices)··2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for linear accelerators to address multiple performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.1, Part No. 8147675, Current R640; Product Usage: The intended us
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i, Part No. 7341428, Current R610/R630; Product Usage: The intended us
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.2, Part No. 10568431, Current R640; Product Usage: The intended use
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended us
Category
Distribution
0 states
HighFDA (Devices)··2013-04-10
Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of
Category
Distribution
0 states
ModerateFDA (Devices)··2013-04-10
Siemens COHERENCE RT Therapist Software Recall for Performance Defects
Siemens is recalling COHERENCE RT Therapist software versions to address performance defects and safety issues identified during final system testing.
Product
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH 2.1, Part No. 8147667, Current R640; Product Usage: The intended use
Category
Distribution
0 states