CLASS II Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
Direct Digital Imaging System recalled by Liebel-flarsheim Company
Liebel-flarsheim Company is recalling Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems, distributed in 30 states. The recall was initiated on 27 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2834-2018
- FDA event ID
- 80174
- Recalling firm
- Liebel-flarsheim Company, Saint Louis, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Feb 2017
- FDA classified
- 21 Aug 2018
- Reported
- 29 Aug 2018
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Imaging Equipment
Timeline
| 27 Feb 2017 | Recall initiated by company | |
| 21 Aug 2018 | Classified by FDA | +540 days |
| 29 Aug 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Liebel-Flarsheim Direct Digital Imaging System (DDIS) 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.
Where it was distributed
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,
AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisKansasKentuckyMarylandMichiganMinnesotaNorth CarolinaNew HampshireNevadaNew York
Questions about this recall
Is Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate recalled?
Yes. Liebel-flarsheim Company recalled Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate on 27 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-2834-2018.
Why was it recalled?
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.
Which lots are affected?
Product ID 750736 SHF-635RF, 750737 SHF-835RF
Where was it sold?
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,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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