Events

Recall of Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171 FE and BA3180-171 FE.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carroll Healthcare Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32093
  • Event Risk Class
    Class 2
  • Event Number
    Z-0919-05
  • Event Initiated Date
    2005-05-17
  • Event Date Posted
    2005-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39114
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, Ac-Powered Adjustable Hospital - Product Code FNL
  • Reason
    The diodes in the control panel may fail, which could result in the thermal breakdown of the circuit board inside of the control box, and cause the bed to cease functioning.
  • Action
    Consignees were sent a fax on 5/17/05 advising them of the problem and instructing them to lock-out the HILO pendant function on the attendant control pad until the firm visits their facility and corrects their beds.

Device

Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 ...
  • Model / Serial
    Serial numbers 374061 through 374065, 374489 through 374519, 374521 through 374531, 375262, 376203 through 376211, 376229 through 376236, 376268 through 376284, 376698, 377647, 377648, 380181, 381593, 382244, 382373 through 382382, 383163 through 383166, 384390 through 384399, 386463 through 386468, 387057 through 387066, 387977 through 388004, 388039 through 388046, 388049 through 388063, 388153 through 388195, 388515 through 388527, 388529, 388679 through 388681, 388728 through 388735 and 389410 through 389414.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Carroll Healthcare brand Arro bed models BA3180-151 AE, BA3180-151 PE, BA3180-151 FE, BA3180-171 AE, BA3180-171 FE and BA3180-171 FE.
  • Manufacturer
    Carroll Healthcare Inc.

Manufacturer

Carroll Healthcare Inc.
  • Manufacturer Address
    Carroll Healthcare Inc., 1881 Huron St, London Canada N6E1P5, Ontario
  • Source
    USFDA