ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #
Summary
The FDA issued a Class II for ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table- by Siemens Medical Solutions USA, Inc. Reason: In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member,.
Details
Source
Device Recall
External ID
Z-1311-2023
Action Date
2023-04-05
Status
Ongoing
Category
device
Product Description
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Lot/Code Info: UDI #: 4056869046877 Serial Numbers: 164011 164013 164018 164019 164021 164022 164024 164025 164026 164027 164028 164033 164034 164048 164049 164053 164054 164055 164057 164060 164061 164063 164064 164066 164068 164069 164071 164072 164073 164074 164075 164080 164083 164084 164086 164094 164095 164097 164098 164100 164105 164113 164115 164121 164124 164125 164134 164138 164140 164142 164152 164153 164155 164157 164158 164159 164160 164161 164163 164168 164171 164172 164173 164183 164184 164186 164187 164188 164189 164190 164196 164201 164202 164204 164205 164210 164211 164212 164213 164216 164227 164228 164231 164234 164240 164241 164242 164244 164250 164253 164263 164267 164269 164270 164275 164277 164279 164282 164287 164292 164293 164295 164297 164298 164299 164300 164303 164306 164311 164312 164315 164318 164319 164321 164322 164326 164328 164329 164330 164331 164332 164333 164338 164340 164344 164352 164353 164355 164359 164362 164366 164371 164377 164389 164391 164394 164397 164398 164399 164400 164403
Quantity Affected: 141 units US
Reason for Recall
In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.
Distribution
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 119 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-1311-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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