CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
DigitalDiagnost C90 Flex/Value/Chest/ER recalled
Philips North America is recalling DigitalDiagnost C90 Flex/Value/Chest/ER, distributed in California. The recall was initiated on 1 May 2026 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-2354-2026
- FDA event ID
- 98940
- Recalling firm
- Philips North America, Cambridge, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 May 2026
- FDA classified
- 5 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 1 May 2026 | Recall initiated by company | |
| 5 Jun 2026 | Classified by FDA | +35 days |
| 17 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.
Where it was distributed
US distribution to California.
Questions about this recall
Why was it recalled?
System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events.
Which lots are affected?
Model Number: 712035. UDI: (01)00884838090705(21)24861049. Lot Code: 24861049.
Where was it sold?
US distribution to California.
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.
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