Digital radiography systems recalled over exceeding the maximum air kerma rate
AGFA Healthcare is recalling 35 DR 800 X-ray systems because it is possible to exceed the maximum allowed air kerma rate of 88mGy/min for pulsed fluoroscopy exams.
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: Scored 3 under the risk-of-harm criterion: the system can exceed the maximum allowed radiation output rate for fluoroscopy, and no injuries are reported.
Plain-English summary
The AGFA Digital Radiography X-Ray system DR 800 with MUSICA Dynamic is being recalled by AGFA Healthcare Corp.
It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. The record states this can happen if the framerate is increased on the NX workstation when ABS is not enabled.
The record lists 35 units. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
Exceeding the maximum allowed air kerma rate means the system can deliver more radiation than the limit permits. The enforcement record reports no injuries. Facilities should follow AGFA's instructions.
The recalled product
- Product
- Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
- Manufacturer
- AGFA Healthcare Corp.
- Affected units
- 35
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 (1)
- N/A
Distribution
Distributed nationwide across the United States.
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