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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86578

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 06, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Arjohuntleigh Magog, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1100-2021
Recall number
Z-1100-2021
Initiated
October 06, 2020
Classification
Class II
Status
Terminated
Recalling firm
Arjohuntleigh Magog, Inc.
Quantity
3390 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)

Code information

LBA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx, LBX1033-xx, KTS0010

Distribution pattern

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.