The Recall Desk
HighFDA (Devices)·Z-2467-2015·Announced 2015-09-02

Sunrise Medical Recalls Quickie IRIS Wheelchairs with Dynamic Backrest

Sunrise Medical is recalling 64 Quickie IRIS wheelchairs because the backrest system may break, posing a risk of falls or injury to the occupant.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of harm (fall or injury) from a structural defect in a medical device, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.

Plain-English summary

Sunrise Medical (US) LLC is recalling 64 Quickie IRIS wheelchairs, model EIZ4-2, that were equipped with the MONO Backrest System with the Dynamic Backrest option (option code 183M02). These devices are designed to provide mobility to persons limited to a sitting position.

The recall is being issued because the backrest system may break over time, which could result in a fall or injury to the occupant. The affected units were distributed nationwide in the United States and internationally to Australia, Germany, and Canada. The specific serial number ranges for the recalled units are IRS-046185 to IRS-063437 and IRSE-058994 to IRSE-063928.

Consumers who own these specific wheelchairs should contact Sunrise Medical (US) LLC for further instructions on how to resolve the issue.

The recalled product

Product
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Manufacturer
Sunrise Medical (US) LLC
Category
Medical Device — Mobility Aids
Hazard
Affected units
64

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model EIZ4-2
  • serial number range - IRS-046185-IRS-063437 and IRSE-058994 to IRSE-063928.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sunrise Medical (US) LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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