FDA Medical Device Recalls (openFDA)
PHILIPS MEDICAL SYSTEMS: CombiDiagnost R90 1.0 (709030)
- Recall number
- Z-1087-2024
- Recalling firm
- PHILIPS MEDICAL SYSTEMS
- Product
- CombiDiagnost R90 1.0 (709030)
- Status
- Open, Classified
- Initiated
- 2022-02-11
- Posted
- 2024-02-14
- Terminated
- not on file
- Reason
- While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.
- Root cause
- Software design
- Action
- An Important Product Notice (2021-PD-DXR-034) dated February 15, 2022 was issued via Certified Mail. Philips Field Service Engineers will contact customers to schedule an onsite visit to install update software correcting the issue. Customers are asked to follow the provided instructions to ensure there are no pending images before an exam circulate the notice to all users and to complete and return the response form and circulate the notice to all users of the device for awareness. Contact Philips Customer Care Solutions Center 1-800-722-9377 with questions.
- Quantity
- 86 units
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
- Lot, serial or model codes
- Model: R90 1.0 (709030); UDI DI: 00884838076747; Software version 1.1.1 or higher; Serial numbers: 10000000, 10000002, 10000003, 10000004, 10000006, 10000011, 10000012, 10000020, 10000024, 10000027, 10000049, 10000050, 10000065, 10000066, 10000067, 10000069, 10000078, 10000081, 10000099, 10000103, 10000107, 10000140, 10000145, 10000152, 10000180, 10001001, 10001010, 10001095, 591362, SN16000009, SN17000003, SN17000007, SN17000015, SN17000022, SN17000111, SN17000114, SN17000118, SN17000120, SN17000121, SN17000122, SN17000123, SN17000128, SN17000129, SN17000130, SN17000145, SN17000146, SN17000147, SN17000148, SN17000153, SN17000157, SN17000163, SN17000165, SN17000166, SN18000003, SN18000004, SN18000010, SN18000021, SN18000025, SN18000033, SN18000037, SN18000038, SN18000044, SN18000045, SN18000053, SN18000054, SN18000057, SN18000060, SN18000068, SN18000069, SN18000079, SN19000004, SN19000006, SN19000011, SN19000020, SN19000034, SN19000036, 27, 40, 41, 42, 77, 101, 131, 155, 180, 190;
- 510(k) numbers
- ["K163210"]
- PMA numbers
- not on file
- Product code
- JAA
- Firm FEI
- 3017726341
- 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