Recall Z-1992-2021— LIEBEL-FLARSHEIM COMPANY LLC

Name: FDA recall Z-1992-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-11

Class II · Terminated

Class II FDA medical device recall by LIEBEL-FLARSHEIM COMPANY LLC, initiated 2021-03-11, terminated 2024-09-18. It names one FDA 510(k) clearance: K121838. Product: HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW). Reason: 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..

Recalling firm: LIEBEL-FLARSHEIM COMPANY LLC
Classification: Class II
Status: Terminated
Initiated: 2021-03-11
Terminated: 2024-09-18
Firm location: Saint Louis, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K121838 — LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEMLiebel-Flarsheim·cleared 2012-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.