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Terminated

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

FDA Recall Z-1992-2021 · Posted None

Recalling FirmLIEBEL-FLARSHEIM COMPANY LLC
Recall StatusTerminated
Product CodeMQB
Date Initiated2021-03-11
Date Terminated2024-09-18
Product Quantity17

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.

Firm Action

The product can be brought into compliance via a software update. The firm plan to have the updated software installed, working with customer schedules, over the course of the next 12 months.

Root Cause

Radiation Control for Health and Safety Act

Distribution Pattern

US Nationwide Distribution and in the country of Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121838LIEBEL-FLARSHEIM DIRECT DIGITAL IMAGING SYSTEMLiebel-Flarsheim · 2012-07-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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