The Recall Desk
HighFDA (Devices)·Z-3178-2018·Announced 2018-09-26

Permobil Recalls Powered Wheelchairs Due to Backrest Bar Failure Risk

Permobil is recalling 3,134 powered wheelchairs because backrest support bars may fail, potentially causing users to fall backward and sustain injuries.

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 is classified as FDA Class II and involves a risk of injury from falling, but the source text does not report any actual injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Permobil, Ab is recalling 3,134 units of powered wheelchairs, including models M300 PS, C300 PS, C350 PS, C500 PS, and C400 PS. The recall is being conducted under FDA Class II classification. The affected devices are intended to provide indoor and outdoor mobility to persons limited to a seated position.

The recall was initiated due to a potential failure of one or both backrest bars that provide back support. If the telescoping bars fail, the user could fall backward, leading to a potential injury. The source text does not report any specific instances of injury or death associated with this defect.

Affected units were distributed worldwide and across the United States. Consumers should check their wheelchair model and serial number against the list provided in the official recall notice to determine if their device is affected.

The recalled product

Product
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchai
Manufacturer
Permobil, Ab
Affected units
3,134

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 (3)

  • (a) M300 PS
  • Serial Numbers: 2557000479 2557000768 (e) C400 PS
  • Serial Numbers: None- seat only

Distribution

Distributed nationwide across the United States.