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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1182-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1183-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1184-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1185-2017 | Class II | Terminated | Voluntary: Firm initiated |
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