Severity
Moderate
FDA Devices recall · Reported June 17, 2015
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
Agfa Healthcare Corp. recalled AGFA DX-D 100 is a mobile digital radiography x-ray system - a moderate-severity action.
AGFA DX-D 100 is a mobile digital radiography x-ray system was recalled by Agfa Healthcare Corp. in June 17, 2015. Reason: When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit …. Check the official notice for the remedy. Verify recall #Z-1745-2015 with the FDA Devices before acting.
The recall
Agfa Healthcare Corp. issued this moderate-severity FDA Devices recall-When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1745-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1745-2015) was formally reported on June 17, 2015, with the manufacturer initiating the action on May 29, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Agfa Healthcare Corp. is listed as the recalling firm, operating out of Greenville, SC. Federal records list the affected scope as 233 units.
The documented reason for this recall is: When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur. Distribution data in the federal record shows the product reached: US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.. Distribution scope 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, 3 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.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Severity
Moderate
Affected scope
233 units
Related Recalls
6
3 from same agency
AGFA DX-D 100 is a mobile digital radiography x-ray system
When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1745-2015 |
| Date reported | June 17, 2015 |
| Date initiated | May 29, 2015 |
| Recalling firm | Agfa Healthcare Corp. |
| Firm location | Greenville, SC |
| Affected scope | 233 units |
| Distribution | US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY. |
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.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 17, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.