Agfa Healthcare Recalls NX 3.0.8950 Imaging Processing Software
Agfa Healthcare is recalling NX 3.0.8950 software because it may temporarily display and transmit incorrect patient images to PACS systems.
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 medical device software defect that results in the transmission of incorrect patient images, which poses a risk of harm through misdiagnosis or treatment errors, but no injuries or illnesses have been reported.
Plain-English summary
Agfa Healthcare Corp. is recalling 221 units of NX 3.0.8950 Imaging Processing Software. The recall was initiated after a customer reported that when using an NX workstation with this specific software version, selecting an affected patient or exam from closed exams initially linked and displayed the wrong image.
Although the wrong image was replaced by the correct image after a short time, the incorrect image was used for transmitting to the Picture Archiving and Communication System (PACS). The affected software was distributed in 33 U.S. states, the District of Columbia, and Canada.
Healthcare facilities should contact Agfa Healthcare for instructions on how to resolve the issue. No specific corrective action or replacement timeline is provided in the source text.
The recalled product
- Product
- Agfa Healthcare NX 3.0.8950 Imaging Processing Software
- Manufacturer
- AGFA Healthcare Corp.
- Affected units
- 221
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)
- 2UA15205XC
- 2UA161JNH
- A5411002007
- A5411001003
- A5411001002
- 5CG5164040
- 2UA5481BVY
- 5CG5171X81
- A5411002026
- A5411002025
- A5410000039
- 2UA62524PS
- 2UA62524Q2
- 2UA62524RK
- A5411002031
- 2UA61218G4
- 5CG61266X6
- 2UA61218GG
- 2UA63825HQ
- 2UA642306H
Distribution
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