Z-2076-2019Class II

U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower...

Name: Z-2076-2019 U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower...
Creator: Laborie Medical Technologies, Corp
Published: 2019-07-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2019-07-17 / Terminated / root cause: manufacturing process

FDA source

LABORIE MEDICAL TECHNOLOGIES, CORP began a recall of U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions on 2019-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2076-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-17
Posted: 2019-07-25
Terminated: 2023-07-10
Recalling firm: Abbott Medical
Product: U3-3 Solar Blue, Laptop integrated power supply used with the Solar Blue Urodynamics for assessing lower urinary tract dysfunctions
Product code: FEN Device, Cystometric, Hydraulic
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Laborie issued letter via FedX on July 17, 2019 advising of the problem, health risk, and action to take: Quarantine the product and unplug the power supply from the wall socket until a replacement is provided. A new power supply unit(s) will be provided along with instructions on how to replace the power supplie in the field. Contact Laborie/MMS customer care with any questions, concerns or problems: Laborie MMS Customer Care Address: 400 Avenue D, Suite 10, Williston, VT 05495 Phone Number: 800.522.6743 Email: [email protected]
Quantity in commerce: 2 US
Distribution: US distribution in AZ, and PA.
Product codes and lots: Serial Numbers: PE18-7SBL1452, PE18-7SBL 1414

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2076-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2076-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-25

Product code FEN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)