Z-1184-2017Class II
Foot Section - BAR5490IVC
Invacare GmbH / initiated 2016-12-02 / Terminated / root cause: design
Invacare Corporation began a recall of Foot Section - BAR5490IVC 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-1184-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Invacare GmbH
- Product
- Foot Section - BAR5490IVC
- 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.
- Quantity in commerce
- 292 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
- BAR5490IVC
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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