Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported August 20, 2014
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Unit was mislabeled with a factory label showing 32 KW output power.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Agfa Healthcare Corp. recalled Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in… - a low-severity action.
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in… was recalled by Agfa Healthcare Corp. in August 20, 2014. Reason: Unit was mislabeled with a factory label showing 32 KW output power.. Check the official notice for the remedy. Verify recall #Z-2176-2014 with the FDA Devices before acting.
The recall
Agfa Healthcare Corp. issued this low-severity FDA Devices recall-Unit was mislabeled with a factory label showing 32 KW output power..
- Low
- severity level
- 1 units
- affected scope
- Class III
- classification
- August 20, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2176-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2176-2014) was formally reported on August 20, 2014, with the manufacturer initiating the action on May 13, 2014. It is classified under Low severity (Class III), 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 1.
The documented reason for this recall is: Unit was mislabeled with a factory label showing 32 KW output power. Distribution data in the federal record shows the product reached: US in the state of WV. 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.
Medical Devices recalls over time
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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1
Related Recalls
6
3 from same agency
Product description
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Reason for recall
Unit was mislabeled with a factory label showing 32 KW output power.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2176-2014 |
| Date reported | August 20, 2014 |
| Date initiated | May 13, 2014 |
| Recalling firm | Agfa Healthcare Corp. |
| Firm location | Greenville, SC |
| Affected scope | 1 |
| Distribution | US in the state of WV |
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.
- Check the recall number (Z-2176-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.. Recalled by Agfa Healthcare Corp.. Units affected: 1.
Why was this product recalled? ▼
Unit was mislabeled with a factory label showing 32 KW output power.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2014. Severity: Low. Recall number: Z-2176-2014.
Where was the recalled product distributed? ▼
Distribution: US in the state of WV.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2176-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 August 20, 2014. 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.