ModerateClass IITerminated

FDA Devices recall · Reported August 29, 2018

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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2833-2018.

Q: Where was the recalled product distributed?

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,.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-2833-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 mode…

Recall #: Z-2833-2018
Affected scope: 313
Initiated: February 27, 2017

Compiled from official public sources by the editorial team.

Verify with FDA Devices →

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Liebel-flarsheim Company LLC recalled Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology sys… - a moderate-severity action.

Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology sys… was recalled by Liebel-flarsheim Company LLC in August 29, 2018. Reason: Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic e…. Check the official notice for the remedy. Verify recall #Z-2833-2018 with the FDA Devices before acting.

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The recall

Liebel-flarsheim Company LLC issued this moderate-severity FDA Devices recall-Software issue. The difference between the display and dosimeter readings In the Child/Pediatric automatic e….

Moderate
severity level: 313 units
affected scope: Class II
classification: August 29, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2833-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2833-2018) was formally reported on August 29, 2018, with the manufacturer initiating the action on February 27, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Liebel-flarsheim Company LLC is listed as the recalling firm, operating out of Saint Louis, MO. Federal records list the affected scope as 313.

The documented reason for this recall is: 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 dos… Distribution data in the federal record shows the product reached: 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,. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

313

Related Recalls

0 from same agency

Product description

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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2833-2018
Date reported	August 29, 2018
Date initiated	February 27, 2017
Recalling firm	Liebel-flarsheim Company LLC
Firm location	Saint Louis, MO
Affected scope	313
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,

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

313 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2833-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2833-2018.

Where was the recalled product distributed? ▼

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,.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-2833-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 29, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.