Recall Z-2270-2013— Invacare Corporation
Class II · Terminated
Class II FDA medical device recall by Invacare Corporation, initiated 2013-06-04, terminated 2016-01-04. It names 2 FDA 510(k) clearances: K023589, K993413. Product: Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.. Reason: Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks..
- Recalling firm
- Invacare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-04
- Terminated
- 2016-01-04
- Firm location
- Elyria, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K023589 — STORM TDX POWER WHEELCHAIR
- K993413 — STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.
Reason for recall
Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
Data sourced from openFDA. This site is unofficial and independent of the FDA.