CLASS II Device recall · Reported 26 Jun 2013 · FDA Enforcement Report
Artiste with syngo RT Therapist recalled
Siemens Medical Solutions USA is recalling Artiste with syngo RT Therapist. The recall was initiated on 29 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1562-2013
- FDA event ID
- 65435
- Recalling firm
- Siemens Medical Solutions USA, Martinez, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 May 2013
- FDA classified
- 20 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Imaging Equipment
Timeline
| 29 May 2013 | Recall initiated by company | |
| 20 Jun 2013 | Classified by FDA | +22 days |
| 26 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Where it was distributed
Worldwide distribution
Questions about this recall
Is Artiste with syngo RT Therapist recalled?
Yes. Siemens Medical Solutions USA recalled Artiste with syngo RT Therapist on 29 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1562-2013.
Why was it recalled?
The potential for a safety issue, for the image quality degradation, that is addressed by the Customer Safety Advisory Notice when verifying the patient position based on 2D images that were acquired as single-exposure MV or In-Line kView images using the syngo RT Therapist 4.3.
Which lots are affected?
All units of the version 4.3, Part No. 08162815
Where was it sold?
Worldwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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