FDA Devices recall · Reported July 20, 2022
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
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 fi…
Philips Medical Systems Dmc GmbH recalled DigitalDiagnost C90 High Performance. radiography and fluoroscopy system - a moderate-severity action.
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system was recalled by Philips Medical Systems Dmc GmbH in July 20, 2022. Reason: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallsta…. Check the official notice for the remedy. Verify recall #Z-1328-2022 with the FDA Devices before acting.
The recall
Philips Medical Systems Dmc GmbH issued this moderate-severity FDA Devices recall-Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallsta….
- Moderate
- severity level
- Class II
- classification
- July 20, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1328-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
DigitalDiagnost C90 High Performance. radiography and fluoroscopy system
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1328-2022 |
| Date reported | July 20, 2022 |
| Date initiated | May 19, 2021 |
| Recalling firm | Philips Medical Systems Dmc GmbH |
| Firm location | Hamburg |
| Affected scope | 140 systems in total, (Updated 1/30/2023). |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1328-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026