Z-2354-2026Class II

DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035

Name: Z-2354-2026 DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035
Creator: Philips North America Llc
Published: 2026-05-01
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2026-05-01 / Open, Classified / root cause: design

FDA source

Philips North America Llc began a recall of DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035 on 2026-05-01. FDA classified it as Class II and gives the reason as "System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2354-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-01
Posted: 2026-06-05
Recalling firm: Philips North America LLC
Product: DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Product code: MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Reason for recall: System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Root cause tag: design
FDA root cause: Device Design
Action: Philips Medical notified the single consignee on about 05/01/2026 via mailed letter. The consignee was notified of the issue, potential risk, and instructed to Stop using the Wall Stand VS2 immediately to ensure patient and user safety while Philips provides the Seismic Bucky Unit 2 (BU2) Skyplate kit, do not attempt to inspect, adjust, or install any mechanical components of the Wall Stand yourself, circulate this Urgent Medical Device Correction letter to all users of this device so that they are aware of the issue and associated impact, and complete and return the provided response form. A Philips representative will contact the consignee to schedule a time for a Field Service Engineer (FSE) to visit the site to install a hardware correction.
Quantity in commerce: 1 unit
Distribution: US distribution to California.
Product codes and lots: Model Number: 712035. UDI: (01)00884838090705(21)24861049. Lot Code: 24861049.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2354-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2354-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05

Product code MQB

K202564Class IIDigitalDiagnost C90Philips Medical Systems Dmc GmbH / cleared 2020-09-30

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)