CLASS II Device recall · Reported 21 Jun 2017 · FDA Enforcement Report
Merge PACS recalled by Merge Healthcare
Merge Healthcare is recalling Merge PACS, distributed nationwide in the US. The recall was initiated on 8 May 2017 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-2591-2017
- FDA event ID
- 77249
- Recalling firm
- Merge Healthcare, Hartland, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 May 2017
- FDA classified
- 15 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 8 May 2017 | Recall initiated by company | |
| 15 Jun 2017 | Classified by FDA | +38 days |
| 21 Jun 2017 | 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
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, including digital mammography
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
When cut lines are shown on an image, the lines may go from being vertical and then shift to horizontal causing confusion to the physician. This may cause a misdiagnosis.
Which lots are affected?
Versions 7.0.2.1, 7.0.2.2, 7.0.2.3, 7.0.2.3 P1, and 7.0.2.3 P2
Where was it sold?
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.
More recalls from Merge Healthcare
All 96| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Merge OrthoPACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | Merge PACS, medical imaging diagnostic workstation recalled | Merge Healthcare | Other | Nationwide |
| Device | CLASS II | The Merge Hemo recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Vericis, Merge Cardio recalled by Merge Healthcare | Merge Healthcare | Device Malfunction | WI |
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 |