AGFA Medical Image Storage Device Recall for Data Loss Risk
AGFA Corp. is recalling IMPAC and IMPAX CV DICOMStore devices because misconfiguration may cause loss of patient data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (loss of patient data) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
AGFA Corp. is recalling 535 units of the AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS). These are medical image storage devices distributed nationwide in the United States, the Virgin Islands, and Canada.
The recall is due to a risk of patient data loss that can occur under certain circumstances caused by misconfiguration of the DICOMstore software when used with the Media Purge Daemon or Cardiovascular Purge Services. The recall covers all software versions of DICOMstore in combination with these specific services.
Healthcare facilities and users of these devices should contact AGFA Corp. for instructions on how to resolve the configuration issue and prevent data loss.
The recalled product
- Product
- AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
- Manufacturer
- AGFA Corp.
- Hazard
- Affected units
- 535
Distribution
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