FDA Medical Device Recalls (openFDA)
Philips North America Llc: DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
- Recall number
- Z-0272-2024
- Recalling firm
- Philips North America Llc
- Product
- DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
- Status
- Open, Classified
- Initiated
- 2023-09-21
- Posted
- 2023-11-08
- Terminated
- not on file
- Reason
- Potential for units suspended on the ceiling to fail and fall.
- 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 pd.cnr@philips.com. 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
- 13 units
- Distribution
- Nationwide distribution.
- Lot, serial or model codes
- Model No. 712029 & 712033; UDI: (01)00884838074521(21) SN19000272, (01)00884838074521(21) SN19000213 , (01)00884838074521(21) 10001077, (01)00884838074521(21) SN20000097, (01)00884838074521(21) SN16000074, (01)00884838074521(21) SN15000238, (01)00884838074521(21) SN16000075, (01)00884838074521(21) SN15000367, (01)00884838074521(21) SN18000428, (01)00884838074521(21) SN17000318, (01)00884838074521(21) SN18000309, (01)00884838074521(21) SN18000204; Serial No. SN15000409, SN19000272, SN19000213, 10001077, SN20000097, SN16000074, SN15000238, SN16000075, SN15000367, SN18000428, SN17000318, SN18000309, SN18000204.
- 510(k) numbers
- ["K210692"]
- PMA numbers
- not on file
- Product code
- KPR
- Firm FEI
- 3016618143
- Firm city
- Cambridge
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28