Use caution Medical device recall · FDA · Published May 19, 2021

Philips DigitalDiagnost 4: Incorrect Radiation Dose Risk After System Restart

Philips recalls DigitalDiagnost 4 High Performance radiography systems with incorrect radiation dose risk after system restarts. Affected units may show wrong image orientation and misaligned anatomical markers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1326-2022Medical device Philips Medical Systems ›

Use caution until it’s fixed

Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Updated 1/30/23) Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

Take action

Contact the company

Recalling firmPhilips Medical Systems DMC GmbHDevelopment And Manufacturing Ctr., Rontgenstr. 24-26 · Hamburg, Germany

✎ GovInfoNow plain-language explainer

Philips is recalling certain DigitalDiagnost 4 High Performance radiography systems because a firmware issue can cause incorrect radiation doses and misaligned anatomical markers during imaging. This could lead to improper treatment or unnecessary radiation exposure. Read more at govinfonow.com/recall/62505-philips-digitaldiagnost-4-incorrect-radiation-dose-risk-after-system-restart.

Source Summary by GovInfoNow · govinfonow.com/recall/62505-philips-digitaldiagnost-4-incorrect-radiation-dose-risk-after-system-restart · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1326-2022

Cite this page

“Philips DigitalDiagnost 4: Incorrect Radiation Dose Risk After System Restart.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62505-philips-digitaldiagnost-4-incorrect-radiation-dose-risk-after-system-restart. Based on FDA recall #Z-1326-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1326-2022%22&limit=1).

The FDA announced on May 19, 2021, that Philips Medical Systems DMC GmbH is recalling DigitalDiagnost 4 High Performance radiography and fluoroscopy systems due to a firmware issue. The defect may cause incorrect radiation doses and mispositioned anatomic markers during examinations.

How to tell if you have it

Brand: Philips Medical Systems
Product: DigitalDiagnost 4 High Performance radiography and fluoroscopy system
Model: 712031
Serial Numbers: 10001009, 10001111, 18000123, 19000181, 20010235, 10001039, 17000264, 18000263, 19000297
Quantity: 140 systems

The hazard

According to the FDA, a firmware issue in the Wallstand VS2 board causes an incorrect image orientation and wrong amplimat field selection after specific system restarts. This error may result in an incorrect dose of radiation and mispositioned anatomic markers associated with the opposite side of the anatomy.

Context

GovInfoNow's records show Philips Medical Systems DMC GmbH issued another recall on October 1, 2025, for Philips Precision CRF Model 706400 units requiring extra force to move vertically. Other recent recalls of similar products include Philips Brilliance CT 64 Medical Scanner Recall (August 7, 2026), Philips Brilliance CT Scanners: Unintended Radiation Risk in Software 4.1.10.x (August 7, 2026), and Philips IQon Spectral CT Software 4.7.7.x Recall: Unintended Radiation Risk (August 7, 2026).

How to tell if you have this one

Check for the model number 712031 on the system. Affected units were sold with serial numbers: 10001009, 10001111, 18000123, 19000181, 20010235, 10001039, 17000264, 18000263, 19000297.

Brand
Philips Medical Systems
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide Distribution

Recall number	Product, codes & lots
Z-1325-2022	ProxiDiagnost N90. radiography and fluoroscopy system; Model 706100 - Serial Number - 10001002 10001003 10001009 10001012 10001014 10001017 10001019 10001020 10001021 10001023 10001027 10001028 10001030 10001037 10001038 10001039 10001040 10001041 10001042 10001043 10001044 10001047 10001049 10001051 20000079 Model 706110 10001052 10001058 10001062 10001068 10001087 10001057 10001059 10001064
Z-1326-2022	DigitalDiagnost 4 High Performance. radiography and fluoroscopy system; Model 712031 Serial Numbers - 10001009 10001111 18000123 19000181 20010235 10001039 17000264 18000263 19000297
Z-1327-2022	DigitalDiagnost 4 Flex / Value. radiography and fluoroscopy system; Model 712032 Serial Numbers - 10001088 10001097 10001104 10001112 19000317 10001095 10001102 10001105
Z-1328-2022	DigitalDiagnost C90 High Performance. radiography and fluoroscopy system; Model 712034 Serial Numbers 10001073 10001104 10001108 10001109 10001119 10001126 10001135 10001140 10001144 10001145 10001153 10001156 10001157 10001163 10001170 10001173 10001178 10001179 10001183 10001191 10001192 10001199 10001200 10001201 10001203 10001208 10001210 10001216 10001220 10001231 10001232 10001234 10001235 10001236 10001240 10001241 10001248 10001251 10001261 10001262 10001264 10001270 10001271 10001273 10001275 10001280 21861349 21861369 21861402 21861418 21861456 21861460 21861471 21861475 21861490 21861496 21861497 21861498 21861501 21861502 21861525 21861531 21861542 22860038 22860118
Z-1329-2022	DigitalDiagnost C90 Flex/Value/Chest/ER. radiography and fluoroscopy system; Model 712035 Serial Numbers 21862105 21862107 21862123 21862126 22860027

Based on the official FDA remedy

What to do — step by step

Check System Settings
Verify if the Wallstand VS2 is the default setting after a system restart.
Update Firmware
Contact Philips for firmware updates to correct the issue.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 14 months after the firm started it.

May 19, 2021Firm started the recall
Jul 12, 2022FDA classified it Class II
Jul 20, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62505-philips-digitaldiagnost-4-incorrect-radiation-dose-risk-after-system-restart">Philips DigitalDiagnost 4: Incorrect Radiation Dose Risk After System Restart (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1326-2022 (May 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1326-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.