Recall Z-2076-2019— LABORIE MEDICAL TECHNOLOGIES, CORP
Class II · Terminated
Class II FDA medical device recall by LABORIE MEDICAL TECHNOLOGIES, CORP, initiated 2019-07-17, terminated 2023-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions. Reason: 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.
- Recalling firm
- LABORIE MEDICAL TECHNOLOGIES, CORP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-17
- Terminated
- 2023-07-10
- Firm location
- Williston, VT, United States
Product description
U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.