EasyDiagnost Eleva DRF, Release 5, used to acquire… recallZ-0279-2024 · Philips North America Llc · initiated Sep 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for units suspended on the ceiling to fail and fall.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0279-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 21, 2023
- Posted by the FDA
- Nov 8, 2023
- Recalling firm
- Philips North America Llc
- Quantity
- 40 units
- Product code
- JAA
- FDA submissions
- K031535
- Distribution
- Nationwide distribution.
Product description
EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
Model No. 706050; UDI: (01)00884838074255(21) SN17000007 , (01)00884838074255(21) SN16000025 , (01)00884838074255(21) SN15000051 , (01)00884838074255(21) SN15000049 , (01)00884838074255(21) SN15000056 , (01)00884838074255(21) SN15000055 , (01)00884838074255(21) SN16000046 , (01)00884838074255(21) SN16000041 , (01)00884838074255(21) SN16000011 , (01)00884838074255(21) SN16000029 , (01)00884838074255(21) SN16000024 , (01)00884838074255(21) SN16000028 , (01)00884838074255(21) SN16000042 , (01)00884838074255(21) SN16000030 , (01)00884838074255(21) SN16000044 , (01)00884838074255(21) SN16000051 , (01)00884838074255(21) SN17000001 , (01)00884838074255(21) SN16000049 , (01)00884838074255(21) SN16000043 , (01)00884838074255(21) SN16000061 , (01)00884838074255(21) SN17000003 , (01)00884838074255(21) SN16000052 , (01)00884838074255(21) SN16000056 , (01)00884838074255(21) SN17000011 , (01)00884838074255(21) SN17000002 , (01)00884838074255(21) SN17000025 , (01)00884838074255(21) SN17000006 , (01)00884838074255(21) SN17000031 , (01)00884838074255(21) SN17000028 , (01)00884838074255(21) SN17000038 , (01)00884838074255(21) SN17000022 , (01)00884838074255(21) SN18000009 , (01)00884838074255(21) SN17000035 , (01)00884838074255(21) SN17000027 , (01)00884838074255(21) SN17000026 , (01)00884838074255(21) SN18000004 , (01)00884838074255(21) SN18000008 , (01)00884838074255(21) SN18000002 , (01)00884838074255(21) SN18000001 , (01)00884838074255(21) SN15000014; Serial No. SN17000007, SN16000025, SN15000051, SN15000049, SN15000056, SN15000055, SN16000046, SN16000041, SN16000011, SN16000029, SN16000024, SN16000028, SN16000042, SN16000030, SN16000044, SN16000051, SN17000001, SN16000049, SN16000043, SN16000061, SN17000003, SN16000052, SN16000056, SN17000011, SN17000002, SN17000025, SN17000006, SN17000031, SN17000028, SN17000038, SN17000022, SN18000009, SN17000035, SN17000027, SN17000026, SN18000004, SN18000008, SN18000002, SN18000001, SN15000014.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EasyDiagnost Eleva 9890-010-03632Philips Medical Systems DMC GmbH · Table, radiographic, tilting1 recall2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93200).
- Z-0271-2024 · Open, ClassifiedCombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
- Z-0272-2024 · Open, ClassifiedDigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
- Z-0273-2024 · Open, ClassifiedDigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
- Z-0274-2024 · Open, ClassifiedDigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
- Z-0275-2024 · Open, ClassifiedDigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
- Z-0276-2024 · Open, ClassifiedDigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
- Z-0280-2024 · Open, ClassifiedProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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