FDA Medical Device Recalls (openFDA)
Philips North America, LLC: ProxiDiagnost N90
- Recall number
- Z-3023-2020
- Recalling firm
- Philips North America, LLC
- Product
- ProxiDiagnost N90
- Status
- Terminated
- Initiated
- 2019-11-20
- Posted
- not on file
- Terminated
- 2024-04-04
- Reason
- Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips sent an Urgent Field Safety Notice dated August 5, 2020 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Philips plans to correct the defect at no cost to customers by implementing a field correction involving the installation of a software update. A Philips Field Service Engineers will schedule an appointment with customers to install the software update.
- Quantity
- 71
- Distribution
- United States
- Lot, serial or model codes
- All ProxiDiagnost N90 systems are affected.
- 510(k) numbers
- K173433
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 1218950
- Firm city
- Andover
- 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