Z-0785-2013Class II

Solara 3G Custom Manual Wheelchair

Name: Z-0785-2013 Solara 3G Custom Manual Wheelchair
Creator: Invacare Corporation
Published: 2012-09-10
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2012-09-10 / Terminated / root cause: manufacturing process

FDA source

Invacare Corporation began a recall of Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position on 2012-09-10. FDA classified it as Class II and gives the reason as "The potential exists for the wheel to rotate freely despite engagement of hub brake". 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-0785-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-10
Posted: 2013-02-04
Terminated: 2014-05-13
Recalling firm: Invacare GmbH
Product: Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
Product code: IOR Wheelchair, Mechanical
Reason for recall: The potential exists for the wheel to rotate freely despite engagement of hub brake.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Invacare sent an URGENT: RECALL INFORMATION Letter dated September 10, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1) Complete the Provider Response Card indicating your receipt and understanding of these instructions. 2) Contact your customers to inform them of the recall. It is recommended that you provide them with the enclosed Customer Letter. Set up an appointment to correct the customer's wheelchair as soon as possible. 3) Please examine the wheelchair to confirm it has one of the serial numbers listed above. The serial number can be found on the front lower crossbar located on the right while sitting in the chair. 4) Using the enclosed retrofit kit, make the necessary correction. Installation instructions can be found on page 109 of the Solara service manual, which is enclosed. 5) Document the correction of the wheelchair on the enclosed tracking sheet. 6) Using the enclosed pre-paid UPS mailing label and original box, return the replaced parts to the address listed on the label. 7) Fax or email the Provider Response Form and tracking sheet to 330-329-3458 or [email protected]. For questions please contact Invacare Customer Service at 800-333-6900.
Quantity in commerce: 3 units
Distribution: US Nationwide Distribution including the states of CA & MT.
Product codes and lots: Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0785-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0785-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-13	2013-02-04

Product code IOR

K984447Class IModel Action at II Manual WheelchairInvacare Corp. / cleared 1999-01-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)