ClearanceBrief
Recall Z-1182-2017 ยท LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

Invacare Corporation

Bariatric Bed - BAR600IVC

DateDec 2, 2016
StatusTerminated
ReasonThe junction box used in the bariatric bed may emit sparks and result in a fire.
Root causeComponent design/selection
ActionAll 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.
Quantity411 Units
DistributionProducts 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
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.