CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
Arjo Flat Dynamic Positioning System (DPS) recalled
Arjohuntleigh Magog is recalling Arjo Flat Dynamic Positioning System (DPS), distributed nationwide in the US. The recall was initiated on 6 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1100-2021
- FDA event ID
- 86578
- Recalling firm
- Arjohuntleigh Magog, Magog, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2020
- FDA classified
- 9 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 6 Oct 2020 | Recall initiated by company | |
| 9 Feb 2021 | Classified by FDA | +126 days |
| 17 Feb 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, GA, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NH, NY, OH, OK, SC, SD, TN, TX, UT, VA, WI and the countries of Australia, Belgium, Canada, Czech Republic, France, Italy and Poland.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMichiganMinnesotaMissouri
Questions about this recall
Is Arjo Flat Dynamic Positioning System (DPS) recalled?
Yes. Arjohuntleigh Magog recalled Arjo Flat Dynamic Positioning System (DPS) on 6 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-1100-2021.
Why was it recalled?
Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)
Which lots are affected?
LBA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx, LBX1033-xx, KTS0010
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, GA, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NH, NY, OH, OK, SC, SD, TN, TX, UT, VA, WI and the countries of Australia, Belgium, Canada, Czech Republic, France, Italy and Poland.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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