Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Reported: April 3, 2013 Initiated: March 8, 2013 #Z-0997-2013
Product Description
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Reason for Recall
The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 81
- Distribution
- Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 81.
Why was this product recalled? ▼
The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions, executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-0997-2013.
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