Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be use
FDA device recall Z-2775-2015 · posted 2015-09-16 · Terminated
Recall details
- Recalling firm
- Bayer Healthcare
- 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.
- Action taken
- Direct accounts were notified by UPS Notification letter dated August 4, 2015 and advised when using the Arterion Injection System to ensure that purges are completed to avoid the injection of air.
- Root cause
- Software design
- Status
- Terminated
- Product code
- DXT
- Quantity affected
- 71
- Distribution
- Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
- Date initiated
- 2015-08-04
- Date posted
- 2015-09-16
- Date terminated
- 2016-08-17
- Location
- Indianola, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE (K132928) | Medrad, Inc. / Bayer Medical Care, Inc. | 2014-01-23 |