Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1182-2017Class II

Bariatric Bed - BAR600IVC

Invacare GmbH / initiated 2016-12-02 / Terminated / root cause: design

Invacare Corporation began a recall of Bariatric Bed - BAR600IVC on . FDA classified it as Class II and gives the reason as "The junction box used in the bariatric bed may emit sparks and result in a fire". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1182-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Bariatric Bed - BAR600IVC
Product code
LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Reason for recall
The junction box used in the bariatric bed may emit sparks and result in a fire.
Root cause tag
design
FDA root cause
Component design/selection
Action
All customers were notified via letter with return receipt. This notification will include a provider letter, provider response card, impacted unit list and a consumer letter. Consignees will be instructed conduct sub-recalls as necessary. Follow-up telephone calls will be made to nonresponders.
Quantity in commerce
411 Units
Distribution
Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts
Product codes and lots
BAR600IVC

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1182-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1182-2017Class IITerminatedVoluntary: Firm initiated
Z-1183-2017Class IITerminatedVoluntary: Firm initiated
Z-1184-2017Class IITerminatedVoluntary: Firm initiated
Z-1185-2017Class IITerminatedVoluntary: Firm initiated