CLASS II ONGOING Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
DigitalDiagnost 4 High Performance recalled
Philips Medical Systems DMC is recalling DigitalDiagnost 4 High Performance, distributed nationwide in the US. The recall was initiated on 19 May 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1326-2022
- FDA event ID
- 90490
- Recalling firm
- Philips Medical Systems DMC, Hamburg
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 May 2021
- FDA classified
- 12 Jul 2022
- Reported
- 20 Jul 2022
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 19 May 2021 | Recall initiated by company | |
| 12 Jul 2022 | Classified by FDA | +419 days |
| 20 Jul 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
DigitalDiagnost 4 High Performance. radiography and fluoroscopy system
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model 712031 Serial Numbers - 10001009 10001111 18000123 19000181 20010235 10001039 17000264 18000263 19000297
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 90490| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ProxiDiagnost N90 recalled by Philips Medical Systems DMC | Philips Medical Systems DMC | Other | Nationwide | |
| CLASS II | DigitalDiagnost C90 High Performance recalled | Philips Medical Systems DMC | Other | Nationwide | |
| CLASS II | DigitalDiagnost C90 Flex/Value/Chest/ER recalled | Philips Medical Systems DMC | Other | Nationwide | |
| CLASS II | DigitalDiagnost 4 Flex / Value recalled by Philips Medical Systems DMC | Philips Medical Systems DMC | Other | Nationwide |
More recalls from Philips Medical Systems DMC
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DigitalDiagnost 4 High Performance, Flex/Value recalled | Philips Medical Systems DMC | Other | Nationwide |
| Device | CLASS II | CombiDiagnost R90 recalled by Philips Medical Systems DMC | Philips Medical Systems DMC | Other | Nationwide |
| Device | CLASS II | ProxiDiagnost N90 recalled by Philips Medical Systems DMC | Philips Medical Systems DMC | Other | Nationwide |
| Device | CLASS II | Precision CRF recalled by Philips Medical Systems DMC | Philips Medical Systems DMC | Other | Nationwide |
| Device | CLASS II | DigitalDiagnost C90 High Performance, Flex/Value/Chest/ER recalled | Philips Medical Systems DMC | Other | Nationwide |
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