Z-0275-2024Class II

DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital...

Name: Z-0275-2024 DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital...
Creator: Philips North America Llc
Published: 2023-09-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2023-09-21 / Open, Classified

FDA source

Philips North America Llc began a recall of DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images on 2023-09-21. FDA classified it as Class II and gives the reason as "Potential for units suspended on the ceiling to fail and fall". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0275-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-21
Posted: 2023-11-08
Recalling firm: Philips North America LLC
Product: DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall: Potential for units suspended on the ceiling to fail and fall.
FDA root cause: Under Investigation by firm
Action: The firm distributed recall notifications dated 8/31/2023 via FedEx to affected consignees. Consignees are instructed to immediately stop use of affected devices and contact their local Philips service representative if the Ceiling Suspension becomes unstable, if moving the Ceiling Suspended X-Ray Tube requires a high amount of force, or if moving the Ceiling Suspended X-Ray Tube is noticeably hampered. The recall notice is to be circulated among all device users, so they are aware of this issue and placed as an addendum in the IFU. Consignees are to complete the provided response form and return it to Philips no later than 30 days from notification receipt via email to [email protected]. Philips will contact consignees to schedule a time for a Field Service Engineer to visit customer sites to inspect affected systems and correct the issue. Consignees with any questions are to contact the Customer Care Solutions Center at 1-800-722-9377.
Quantity in commerce: 33 units
Distribution: Nationwide distribution.
Product codes and lots: Model No. 712035; UDI: (01)00884838090705(21)10000009, (01)00884838090705(21)10000010, (01)00884838090705(21)10000003, (01)00884838090705(21)10000004, (01)00884838090705(21)10000002, (01)00884838090705(21)10000001, (01)00884838090705(21)10000053 , (01)00884838090705(21) 10001042 , (01)00884838090705(21) 10001044 , (01)00884838090705(21) 10001125 , (01)00884838090705(21) 10001113 , (01)00884838090705(21) 10001111 , (01)00884838090705(21) 10001112 , (01)00884838090705(21) 10001109 , (01)00884838090705(21) 10001110 , (01)00884838090705(21) 10001114 , (01)00884838090705(21) 21862107 , (01)00884838090705(21) 10001130 , (01)00884838090705(21) 21862103 , (01)00884838090705(21) 21862101 , (01)00884838090705(21) 21862100 , (01)00884838090705(21) 22860370 , (01)00884838090705(21) 21862123 , (01)00884838090705(21) 21862126 , (01)00884838090705(21) 22860323 , (01)00884838090705(21) 22860045 , (01)00884838090705(21) 22860317 , (01)00884838090705(21) 22860316 , (01)00884838090705(21) 22860318 , (01)00884838090705(21) 22860342 , (01)00884838090705(21) 22860357 , (01)00884838090705(21) 23860320 , (01)00884838090705(21) 23860316; Serial No. 10000009, 10000010, 10000003, 10000004, 10000002, 10000001, 10000053, 10001042, 10001044, 10001125, 10001113, 10001111, 10001112, 10001109, 10001110, 10001114, 21862107, 10001130, 21862103, 21862101, 21862100, 22860370, 21862123, 21862126, 22860323, 22860045, 22860317, 22860316, 22860318, 22860342, 22860357, 23860320, 23860316.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0275-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0271-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0272-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0273-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0274-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0275-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0276-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0277-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0278-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0279-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08
Z-0280-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-08

Product code JAA

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)