Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1183-2017Class II

Bariatric Bed - BARPKG-IVC 1633

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

Invacare Corporation began a recall of Bariatric Bed - BARPKG-IVC 1633 on . FDA classified it as Class II and gives the reason as "A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-1183-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Invacare GmbH
Product
Bariatric Bed - BARPKG-IVC 1633
Product code
LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Reason for recall
A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into 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.
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
BARPKG-IVC 1633

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1183-2017
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