FDA Medical Device Recalls (openFDA)
LIEBEL-FLARSHEIM COMPANY LLC: HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
- Recall number
- Z-1992-2021
- Recalling firm
- LIEBEL-FLARSHEIM COMPANY LLC
- Product
- HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
- Status
- Terminated
- Initiated
- 2021-03-11
- Posted
- not on file
- Terminated
- 2024-09-18
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- 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.
- Quantity
- 17
- Distribution
- US Nationwide Distribution and in the country of Canada
- Lot, serial or model codes
- Product ID/Reorder Number: 705559 (65KW), 705560 (80KW) Model/NDC: HUTSHVDIS
- 510(k) numbers
- K121838
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 3012465398
- Firm city
- Saint Louis
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28