CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report
U3-3 Solar Blue, Laptop integrated power supply used recalled
Laborie Medical Technologies is recalling U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for, distributed in Arizona, Pennsylvania. The recall was initiated on 17 Jul 2019 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-2076-2019
- FDA event ID
- 83310
- Recalling firm
- Laborie Medical Technologies, Williston, VT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2019
- FDA classified
- 25 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 17 Jul 2019 | Recall initiated by company | |
| 25 Jul 2019 | Classified by FDA | +8 days |
| 31 Jul 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
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
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Where it was distributed
US distribution in AZ, and PA.
Questions about this recall
Why was it recalled?
Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard
Which lots are affected?
Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414
Where was it sold?
US distribution in AZ, and PA.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Laborie Medical Technologies
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|---|---|---|---|---|---|
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