ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for s
Summary
The FDA issued a Class II for ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OE by Siemens Medical Solutions USA, Inc. Reason: If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is ac.
Details
Source
Device Recall
External ID
Z-1498-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
Product Description
ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Lot/Code Info: UDI: 04056869046877 S/N: Serial # 164140 164159 164138 164332 164331 164033 164287 164282 164210 164184 164183 164311 164142 164312 164071 164328 164034 164391 164318 164244 164306 164155 164340 164189 164277 164173 164292 164231 164095 164057 164055 164054 164329 164072 164190 164048 164025 164026 164027 164338 164094 164241 164326 164267 164186 164068 164121 164157 164019 164152 164161 164013 164069 164213 164073 164293 164263 164298 164060 164083 164113 164021 164066 164398 164362 164124 164125 164366 164279 164075 164098 164028 164153 164330 164389 164394 164172 164086 164084 164074 164295 164353 164234 164321 164242 164275 164270 164315 164344 164163 164158 164053 164171 164297 164134 164253 164333 164188 164377 164403 164063 164064 164397 164300 164299 164105 164160 164024 164080 164049 164240 164359 164227 164228 164018 164022 164250 164061 164187 164115 164399 164011 164211 164216 164204 164205 164212 164100 164097 164269 164303 164322 164355 164400 164196 164352 164168 164319 164201 164202 164371
Quantity Affected: 141 units US
Reason for Recall
If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If "Adjust C-arm to Ref" is activated when the C-Arm is positioned outside of the working range the C-Arm will reach the target position with an inaccuracy of 5-10 mm. As a result, the message Endposition reached will be displayed .Leading to unintended direction of the movement causing crushing of a patient, staff member, operator, or equipmen Live images may not match the previously stored reference images. Overlay images may be shown inaccurate on anatomy (e.g., DSA Roadmap workflow does not match real anatomy). This may cause e.g., a vessel perforation in DSA roadmap.
Distribution
Worldwide - US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-02
Company
Malvern, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Medical Solutions USA, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Medical Solutions USA, Inc have FDA actions?
Siemens Medical Solutions USA, Inc has 277 FDA actions in our database, including 173 recalls and 104 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1498-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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