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Class 2 Device Recall Acorn Stairlifts |
 |
| Date Initiated by Firm |
February 17, 2016 |
| Create Date |
April 20, 2016 |
| Recall Status1 |
Terminated 3 on January 29, 2019 |
| Recall Number |
Z-1530-2016 |
| Recall Event ID |
73509 |
| Product Classification |
Powered stairway chair lift - Product Code PCD
|
| Product |
Acorn 180 Curved Stairlift |
| Code Information |
Serial Numbers: 140401487591 to 140410249946. All models manufactured before April 2012 |
Recalling Firm/
Manufacturer |
Acorn Stairlifts Inc
7335 Lake Ellenor Dr
Orlando FL 32809-6219
|
| For Additional Information Contact |
Jim Bradley
407-650-0216
|
Manufacturer Reason
for Recall |
Aluminum rivets holding the base squab to the framer under prolonged customer use were seen to elongate and subsequently break.
|
FDA Determined
Cause 2 |
Component change control |
| Action |
Customers were notified by phone calls, documents mailed with a Rationalization Action plan to follow. Contact information 1-888-563-0410 x1500 or 1400 |
| Quantity in Commerce |
1,290 USA and 9,607 Foreign |
| Distribution |
Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, ME, MD, MI, MO, NH, NJ, NY, NC, OH, PA, RI, SC, TN, TX, UT, VT, VI, WA, WV, WI, and District of Columbia and to the countries of UK and Germany. |
| Total Product Life Cycle |
TPLC Device Report
|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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