HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW)
Reported: July 14, 2021 Initiated: March 11, 2021 #Z-1992-2021
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.
Details
- Recalling Firm
- LIEBEL-FLARSHEIM COMPANY LLC
- Units Affected
- 17
- Distribution
- US Nationwide Distribution and in the country of Canada
- Location
- Saint Louis, MO
Frequently Asked Questions
What product was recalled? ▼
HydraVision Digital Imaging System Product ID/Reorder Number: 705559 (65KW). Recalled by LIEBEL-FLARSHEIM COMPANY LLC. Units affected: 17.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-1992-2021.
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