Bayer Medrad Mark 7 Arterion Injection System Software Recall
Bayer Healthcare is recalling 71 Medrad Mark 7 Arterion Injection Systems due to a software defect that removes purge enforcement, potentially affecting angiographic studies.
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 is classified as FDA Class II, and the software defect involves the removal of purge enforcement in a medical device used for human injection, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Bayer Healthcare is recalling 71 units of the Medrad Mark 7 Arterion Injection System. The affected devices utilize Software Version SW 005.006_SH and are used for injecting contrast medium and common flushing solutions into humans for angiographic studies. The recall covers specific catalog numbers (ART 700 PEDL, ART 700 TABL, ART 700 OCS) and a list of 71 specific serial numbers.
The recall is due to a software defect in Version SW 005.006_SH. This version resulted in the removal of purge enforcement from traditional New-Case, Power Up, and Syringe Change use cases while the injector head is in the upright position. This defect may impact the proper functioning of the injector during these specific operational states.
The affected devices were distributed worldwide, including in the United States, Germany, France, the United Kingdom, the Netherlands, Sweden, and Canada. Healthcare facilities and users should stop using the affected units and contact Bayer Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
- Manufacturer
- Bayer Healthcare
- Affected units
- 71
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)
- Catalog numbers: ART 700 PEDL
- ART 700 TABL
- ART 700 OCS
- which utilize Software Version SW 005.006_SH. Affected serial numbers: 20329
- 20570
- 101148
- 20392
- 20425
- 20427
- 30046
- 100945
- 100186
- 21255
- 30086
- 20025
- 101153
- 101159
- 20714
- 100873
- 20437
Distribution
Distributed nationwide across the United States.
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