| | Class 2 Device Recall LiebelFlarsheim Hydra Vision Urology XRay System (DR) |  |
| Date Initiated by Firm | February 27, 2017 |
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| Create Date | August 21, 2018 |
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| Recall Status1 |
Terminated 3 on August 16, 2023 |
| Recall Number | Z-2833-2018 |
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| Recall Event ID |
80174 |
| 510(K)Number | K943581 |
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| Product Classification |
Table, radiographic, tilting - Product Code IXR
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| Product | Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR)
Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics, endourology and minimal invasive urology/ surgery. |
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| Code Information |
Product ID : 750732 SHF-635RF, 750733 SHF-835RF |
Recalling Firm/
Manufacturer |
LIEBEL-FLARSHEIM COMPANY LLC
1034 S Brentwood Blvd
Saint Louis MO 63117-1223
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| For Additional Information Contact |
314-376-4768 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Radiation Control for Health and Safety Act |
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| Action | The firm, Liebel-Flarsheim, notified its customers by phone on or about 2/27/2017 to inform them of the product, problem and actions to be taken. The firm plans to have these Sedecal software updates implemented over the course of the next 12 months.
For additional information, please contact me at 314-376-4788. |
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| Quantity in Commerce | 313 |
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| Distribution | US Distribution to: AL, AZ, CA, CT, CO, FL GA, HI, IA, IL, ID, KS, KY, MD, MI, Michigan, MN, NC, NH, NV, NY, OK, OH, PA, SC, TN, TX, VA, WA, WI, and WV, |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = IXR
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