Reported Dec 18, 2024 · Ongoing
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best · N/A
Is this the product you have?
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following
7 of 7 products
| Model / number | Product as published |
|---|---|
722010. | Allura Xper FD10 |
722011. | Allura Xper FD10/10 |
722012. | Allura Xper FD20 |
722013. | Allura Xper FD20 Biplane |
722022. | Allura Xper FD10 OR Table |
722023. | Allura Xper FD20 OR Table |
722025. | Allura Xper FD20 Biplane OR Table |
- Lot codes and dates
- 1
- Model Number722010
- UDI (Serial Numbers)
763 of 763 codes
(01)00884838054189(21)164 (164)(01)00884838059030(21)272 (272)(01)00884838059030(21)819 (819)(01)00884838059030(21)828 (828)No UDI (3339424365676979107119127158160169177190191209213214215218227229239240241252274280285286290296298306308316342343344360364365395411414422423453468477478480485488
- Model Number722011. No UDI
- Serial Numbers
204 of 204 codes
157833089510734592331949170137173101841551332343451243321022701771323251576791787237255501711682227534432414016317210382154215406927228681224184266175146164334338
- Model Number722012
- UDI (Serial Numbers)
1,392 of 1,392 codes
(01)00884838059054(21)1356 (1356)(01)00884838059054(21)191 (191)(01)00884838059054(21)351 (351)(01)00884838059054(21)583 (583)(01)00884838059054(21)655 (655)(01)00884838059054(21)796 (796)(01)00884838059054(21)950 (950)No UDI (1117100116731712585517154570171550475793512501613200617331734220119227419210341359184886519081166111316594943351804147314081401158857659559023021279215148134854389311871455208522024235251798
- Model Number722013. No UDI
- Serial Numbers
325 of 325 codes
505217313492341534103602907483580160404126244106346461307144243529329746289638342692672144021138660382149424140254255266475518519303194115150496599441491124151179550377575
- Model Number722022. No UDI
- Serial Number6. 6
- Model Number722023. No UDI
- Serial Numbers
94 of 94 codes
271161217598357214246641104912466117109421388283127751184133146121119701124713725114105901077459414131613288739938141328468134795256693721
- Model Number722025. No UDI
- Serial Numbers
326
- Amount recalled
- 2,782 units
Where it was sold
- Nationwide
Why it was recalled
Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Philips Medical Systems Nederland B.v. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.