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FDA · Medical device recall

Acorn 130 Stairlift…

Recall started · FDA enforcement report March 9, 2022 Class II

Reason
The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.
Status
Ongoing
Distribution
Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, and WY, as well as Puerto…

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Enforcement report date
March 9, 2022
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA has not recorded a termination for this recall; FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
Acorn Stairlifts, Inc
Product
Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
Reason
The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.
Distribution pattern
Distributed nationwide to AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, VI, WA, WV, WI, and WY, as well as Puerto Rico and the Virgin Islands. There was no foreign/military/government distribution.
Quantity
26,428
Codes and lots
Acorn 130/180 Seat Squab, included as part of The Acorn 130 Straight Stairlift and the Acorn 180 Curved Stairlift. Serial Numbers…
The first 12,000 characters of this field; the agency record has the rest.
Recall started
April 20, 2016
Voluntary or mandated
Voluntary: Firm initiated
Device type
Powered Stairway Chair Lift
Root cause (FDA)
Component design/selection
What the company told customers
A Recall notification letter titled, "URGENT-MEDICAL DEVICE RECALL" was sent via mail to The recalling firm began notifying direct consumers of the recall via telephone on 4/20/2016. The phone script asked them to confirm the stairlift is still installed at their address and that as a precautionary measure, they are going to replace one of the components on the stairlift. The customer was asked when an appointment could be made. If the customer no longer had the lift installed at their address, they were asked for details on its disposition. No additional details were given to the customer regarding the specific issue or hazard involved. If the direct consumers were unable to be reached via telephone, they were mailed an undated "IMPORTANT RECALL SAFETY NOTICE. ACTION REQUIRED!" It said the safety of their customers is always of paramount importance, therefore, they are to contact the firm. A toll-free telephone number was provided as well as an email address. The reason for recall was explained that one of the stairlift components needs to be replaced and the seat base could weaken over time causing a remote possibility the seat base could crack or separate from the seat assembly. The telephone number was again provided. If the firm is still unable to get a response from the customer, a company field technical would visit the residence to offer to replace the seat in person. If no one was home, a door tag would be left which requests the customer to contact them, and the phone number and email address is provided. The tag also asks if the customer still has the stairlift and if it is no longer there, they would like to know its disposition. The firm issued letters dated 8/6/2021 to distributors via mail on 8/10/2021. The letter explained the issue with seats used in some of the motorized stairlifts. The distributor was instructed to replace existing seats with a replacement seat within 60 days of the date of the letter. If the distributor wa
Recall number
Z-0681-2022

What this record is about

A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.

A generic icon of the kind of thing the record is aboutA simplified icon of the kind of thing the record is about and the phrases of the record's own text beside it.1 The record: Acorn 130 Stairlift, Brooks 130 Stairlift…2 In the record's words:3 Only the kind of thing is drawn4 The record's own words are below“The design of the seats did not consistently have the adequatestrength required to support the customers weight with continued…”ACORN 130 STAIRLIFT…

“The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.”Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift, FDA enforcement report, 2022-03-09. The caption is the record's own words.

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FDA device name: Powered Stairway Chair Lift

Distributed in (FDA's record): Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin Wyoming and nationwide

This recall among the others

  • FDA's enforcement report came 2,149 days after the firm started the recall. For half of the 888 FDA medical device recall events reported in 2022 with a start date, it took 54 days or fewer (by year).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-0681-2022. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-0681-2022, March 9, 2022. "Acorn 130 Stairlift." PlainRecords, https://plainrecords.com/recall/device/z-0681-2022/ (as of the day it was built).

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