CLASS II ONGOING Device recall · Reported 20 Dec 2023 · FDA Enforcement Report
Change Healthcare Stratus Imaging PACS recalled
Change Healthcare Canada is recalling Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of, distributed nationwide in the US. The recall was initiated on 1 Nov 2023 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-0551-2024
- FDA event ID
- 93451
- Recalling firm
- Change Healthcare Canada, Richmond, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2023
- FDA classified
- 14 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 1 Nov 2023 | Recall initiated by company | |
| 14 Dec 2023 | Classified by FDA | +43 days |
| 20 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Product as listed by the FDA
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Where it was distributed
US Nationwide distribution. There was no military/government distribution.
Questions about this recall
Why was it recalled?
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Which lots are affected?
Version 1.4, UDI (01)17540262160093(10)010400
Where was it sold?
US Nationwide distribution. There was no military/government 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.
More recalls from Change Healthcare Canada
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|---|---|---|---|---|---|
| Device | CLASS II | Change Healthcare Radiology Solutions recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemodynamics recalled | Change Healthcare Canada | Device Malfunction | Nationwide |
| Device | CLASS II | McKesson Cardiology Hemo recalled by Change Healthcare Canada | Change Healthcare Canada | Labeling Errors | Nationwide |
| Device | CLASS II | Change Healthcare Cardiology Hemo recalled | Change Healthcare Canada | Labeling Errors | Nationwide |
Other Imaging Equipment recalls
All 2,347| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Computed Tomography X-ray System recalled by Shanghai United Imaging | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |