Liebel-flarsheim Company Llc
2111 EAST GALBRAITH RD., Cincinnati, OH, US
Registered product codes
5 product codes
Recent MDR events
11 on file
- ANGIOMAT ILLUMENA INJECTOR SYSTEMJan 11, 2024MalfunctionMW5150167
- INJECTOR AND SYRINGE, ANGIOGRAPHICJan 8, 2024MalfunctionMW5149964
- INJECTOR AND SYRINGE, ANGIOGRAPHICJan 8, 2024InjuryMW5149965
- INJECTOR AND SYRINGE, ANGIOGRAPHICDec 1, 2023InjuryMW5148715
- INJECTOR AND SYRINGE, ANGIOGRAPHICDec 1, 2023MalfunctionMW5148716
- GUERBET ANGIOMAT ILLUMENA INJECTORJul 15, 2022InjuryMW5110930
- INJECTOR, CONTRAST MEDIUM, AUTOMATICMar 21, 2022Malfunction13839217
- INJECTOR, CONTRAST MEDIUM, AUTOMATICMar 21, 2022Malfunction13839966
- ILLUMENA NEO ANGIOGRAPHIC SYRINGE WITH FILLING SPIKEDec 6, 2021MalfunctionMW5105841
- LF ANGIOMAT ILLUMENAMay 8, 2018Malfunction7494098
Recalls
3 on file
- TerminatedUnknown
Failure to comply with the performance standard for fluoroscopy systems. Per 21 CFR 1020.32(k)(6), the displayed AKR and cumulative air kerma shall not deviate from the actual values by more than 35 percent. The dosage displayed on the generator console and table display (monitor) is higher than the actual delivered dose.
View FDA record ↗ - TerminatedUnknown
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
View FDA record ↗ - TerminatedUnknown
Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic exposure mode is in the range of 52-65%. The display in all other modes deviated by less than 35% from the dosimeter readings.
View FDA record ↗
Compliance history
Matched by FEI 1518293.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.