SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5 recall: Software Issue
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…
Why was SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All units of these models.
- 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…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 621 units (foreign account) in total
- Distribution
- Worldwide Distribution
- Recall date
- April 10, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)