Z-2404-2023Class II

MultiDiagnost-Eleva

Name: Z-2404-2023 MultiDiagnost-Eleva
Creator: Philips Medical Systems Nederland B.V.
Published: 2023-07-19
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2023-07-19 / Open, Classified

FDA source

Philips Medical Systems Nederland B.V. began a recall of MultiDiagnost-Eleva on 2023-07-19. FDA classified it as Class II and gives the reason as "A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2404-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-19
Posted: 2023-09-07
Recalling firm: Philips Medical Systems Nederland B.V.
Product: MultiDiagnost-Eleva
Product code: KPR System, X-Ray, Stationary
Reason for recall: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
FDA root cause: Radiation Control for Health and Safety Act
Action: Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. (Philips reference 2023-IGT-BST-011).
Quantity in commerce: 5432 systems in total
Distribution: US Nationwide Distribution
Product codes and lots: MultiDiagnost-Eleva

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2404-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2402-2023	Class II	Ongoing	FDA Mandated	2023-09-13	2023-09-07
Z-2403-2023	Class II	Ongoing	FDA Mandated	2023-09-13	2023-09-07
Z-2404-2023	Class II	Ongoing	FDA Mandated	2023-09-13	2023-09-07

Product code KPR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)