CLASS II Device recall · Reported 23 Sep 2015 · FDA Enforcement Report

Angiographic Injector recalled by Bayer Healthcare

Bayer Healthcare is recalling Angiographic Injector, distributed nationwide in the US. The recall was initiated on 4 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501

Quantity recalled71

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2775-2015
FDA event ID: 71994
Recalling firm: Bayer Healthcare, Indianola, PA
Classification: Class II
Status: Terminated
Recall initiated: 4 Aug 2015
FDA classified: 16 Sep 2015
Reported: 23 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

4 Aug 2015	Recall initiated by company
16 Sep 2015	Classified by FDA	+43 days
23 Sep 2015	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software Version SW 005.006_SH, 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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.

Nationwide

Questions about this recall

Why was it recalled?

Software Version SW 005.006_SH, 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.

Which lots are affected?

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, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501

Where was it sold?

Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Bayer Healthcare

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15 Feb 2017Device	CLASS II	Medrad Intego PET Infusion System recalled by Bayer Healthcare	Bayer Healthcare	Particulate Matter	Nationwide
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14 Sep 2016Device	CLASS II	Certegra Workstation used in conjunction recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide
27 Jul 2016Device	CLASS II	Angiographic Injector and Syringe recalled by Bayer Healthcare	Bayer Healthcare	Other	NY
20 Jan 2016Device	CLASS II	Medrad Source Administration Sets recalled by Bayer Healthcare	Bayer Healthcare	Other	Nationwide

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