AGFA DX-D100 X-Ray System Recalled for Missing Allen Wrench Storage Instructions
AGFA Healthcare Corp. is recalling 308 DX-D100 Digital Radiography X-Ray Systems because the user manual did not specify where to store the Allen wrench used for manual movement.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a documentation issue (missing storage instructions) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
AGFA Healthcare Corp. is recalling 308 units of the AGFA Digital Radiography X-Ray System DX-D100. The recall was initiated because the DX-D100 User Manual contained instructions for moving the mobile unit manually using an Allen wrench, but it did not indicate where the Allen wrench should be stored.
The affected units were distributed worldwide, including in the United States and Canada. The recall covers specific serial codes listed in the agency's records.
Consumers and healthcare facilities should check their DX-D100 systems to see if they are affected by this recall. The hazard is limited to the lack of storage instructions for the tool in the manual.
The recalled product
- Product
- AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis
- Manufacturer
- AGFA Healthcare Corp.
- Hazard
- Affected units
- 308
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- A5410000053
- A5410000054
- A5411000439
- A5411000446
- A5411000447
- A5411000448
- A5410000067
- A5410000068
- A5410000069
- A5410000070
- A5410000072
- A5410000073
- A5410000100
- A5410000107
- A5410000134
- A5411000184
- A5410000039
- A5411000140
- A5411000142
- A5411000314
Distribution
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