Sunrise Medical (US) LLC: Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part

Is my product affected?

Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).

• UPC 05022408059799

Check against the official notice below — it lists the full affected range.

What happened

Sunrise Medical (US) LLC is recalling one Quickie/Zippie Q700M powered wheelchair due to programming errors in its Power Module RNET 120A Expandable Controller. The error allows end users to increase motor parameters beyond tested safe limits, creating a potential hazard. The affected wheelchair was distributed to a consignee in Montana and can be identified by serial number Q7MP-083941.

The recall record does not specify a remedy or recommended action for consumers who may have this wheelchair.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.

Details from the source

Reason for recall: Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits. Distribution: Distributed to US Consignee in MT. Quantity: 1 Lot/code info: Q700M wheelchair S/N Q7MP-083941. UDI:(01)05022408059799. Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). Controller label: D50903.15 CR19100531.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measure2020-02-13
• Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates2020-02-13
• ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA¿ Chemistry systems. Such measurements are useful in the screeni2020-02-13
• ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates on the ADVIA¿ Chemistry systems. Measurement of total bi2020-02-13
• DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Pa2020-02-13

All FDA (Device enforcement) recalls