The Recall Desk
HighFDA (Devices)·Z-0019-2015·Announced 2014-10-15

ArjoHuntleigh Contoura C1000 and C1080 Bariatric Beds Recalled for Entrapment Risk

Arjo Hospital Equipment AB is recalling 1,695 Contoura C1000 and C1080 bariatric beds worldwide due to a low but existing risk of patient entrapment for individuals with a BMI under 40.

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 product (medical device) where injury has not yet been reported, which aligns with the rubric criteria for a score of 3 (High).

Plain-English summary

Arjo Hospital Equipment AB is recalling 1,695 ArjoHuntleigh Contoura C1000 and C1080 series bariatric beds distributed worldwide. The recall covers units sold in the United States and in numerous international countries, including Australia, Canada, and various European and Middle Eastern nations.

The recall is issued because there is a low but existing entrapment risk for patients being treated on these beds if they have a Body Mass Index (BMI) of less than 40. The Contoura series beds are electrically operating medical beds designed to accommodate patients weighing up to 990 lbs (450 kg) and are intended for use in hospitals to facilitate the management of obese patients.

Healthcare facilities and consumers should identify affected units by checking the model number (C1000 or C1080) and serial numbers against the list provided in the official recall notice. The source text does not specify a corrective action or contact information for the recall.

The recalled product

Product
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura s
Affected units
1,695

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 (20)

  • 1) Model Number: C1000
  • Serial Numbers (Foreign): 62265
  • 399945
  • 399946
  • 399949
  • 416912
  • 416914
  • 423215
  • 475309
  • 530882
  • 554079
  • 554082
  • 566463
  • 584837
  • 586554
  • 592203
  • 592204
  • 592205
  • 592206
  • 597027

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically: