Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution.
Recall record
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product type
- Devices
- Recall number
- Z-1311-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Malvern, PA
- Recall initiated
- 2023-02-02
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1311-2023 · Source: openFDA enforcement.