Injector, Contrast Medium, Automatic
Cardiovascular · 21 CFR 870.1650
Recent MDR events
576 adverse event reports on file
- EMPOWER CTAJul 21, 2026InjuryAcist Medical Systems, Inc.2134243-2026-00013
- INJ, OPTIV, MULIJun 19, 2026MalfunctionLiebel-flarsheim1518293-2026-00024
- INJ. OPTIV DH,SI W/OEMJun 19, 2026MalfunctionLiebel-flarsheim1518293-2026-00023
- EMPOWER CTA+Jun 9, 2026InjuryBracco Injeneering Sa3004753774-2026-00004
- BRACCO INJECTORJun 1, 2026MalfunctionBracco Injeneering S.a.MW5188782
- ULRICH MEDICALMay 29, 2026MalfunctionUlrich Gmbh & Co. Kg9612420-2025-00106
- INJ. OPTIV DH,SI W/OEMMay 19, 2026MalfunctionLiebel-flarsheim1518293-2026-00022
- INJECTMay 12, 2026MalfunctionUlrich Gmbh & Co. Kg25147786
- ULRICH MEDICAL SPIKE FOR CTMay 7, 2026MalfunctionUlrich Gmbh & Co. KgMW5187841
- ULRICH MEDICAL SPIKE FOR CTMay 7, 2026MalfunctionUlrich Gmbh & Co. KgMW5187842
Event type breakdown
Recalls
3 recall events for this product code
- Mallinckrodt IncTerminatedJan 20, 2012
Illumena 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe with Handi-Fil (p/n 900101), Made in Mexico, Liebel-F
Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101.
Z-0830-2012 · View FDA record ↗ - Mallinckrodt IncTerminatedJul 21, 2011
Angiomat Illumena Syringe, 150mL Linden Luer Syringe with Handi-Fil Straw (p/n 900103), in a sealed molded plastic tray.
Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.
Z-2859-2011 · View FDA record ↗ - Mallinckrodt IncTerminatedAug 15, 2008
The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain
Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.
Z-1694-2008 · View FDA record ↗
Registered firms
105 firms currently registered for this product code
Rose Gmbh Fuer Medizintechnik
Trier Rhineland-Palatinate, DE
Bayer Medical Care Inc.
Pittsburgh, PA, US
Acist Medical Systems, Inc.
EDEN PRAIRIE, MN, US
Sidam Srl
Mirandola Modena, IT
Sidam Srl
Mirandola Modena, IT
Ulrich Gmbh & Co. Kg
ULM Baden-Wurttemberg, DE
Sterigenics Us, Llc
Lewis Center, OH, US
Emotechnic
Casablanca, MA
Advanced Imaging Services, Inc.
Lathrop, CA, US
Sterigenics U.s., Llc
Queensbury, NY, US
Can Technomed Trading Ltd.
Richmond British Columbia, CA
Sterlab
SIGNES Var, FR
Bracco Injeneering S.a.
LAUSANNE Vaud, CH
Promedtech
Fouchena Tunis, TN
510(k) clearances
23 clearances for this product code
- ACIST Medical Systems, Inc.Aug 3, 2026
K262115 · VueJect® Ultrasound Enhancing Agent Delivery System
- Ulrich GmbH & Co. KGNov 18, 2025
K252281 · ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- Ulrich GmbH & Co. KGNov 7, 2025
K251295 · ulrichINJECT CT Motion (XD 8000)
- Imaxeon Pty, Ltd.Sep 24, 2025
K252689 · MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
- Imaxeon Pty, Ltd.Nov 5, 2024
K241849 · MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)
- Ulrich GmbH & Co. KGAug 26, 2024
K241850 · ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- Ulrich GmbH & Co. KGApr 19, 2024
K233737 · ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- Ulrich GmbH & Co. KGAug 6, 2021
K210541 · ulrichINJECT CT motion