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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67924

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 18, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SCM True Air Technologies LLC

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

3 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 3

JK Bariatric Beds, True Air Technologies, Inc.

Z-1630-2014
Recall number
Z-1630-2014
Initiated
March 18, 2014
Classification
Class II
Status
Terminated
Quantity
24 beds

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

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

The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

Code information

Serial #'s 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, 4735

Distribution pattern

Nationwide Distribution including GA, KY, and MI.

device · product 2 of 3

ECATS E 850 Bariatric Bed, True Air Technologies, Inc.

Z-1631-2014
Recall number
Z-1631-2014
Initiated
March 18, 2014
Classification
Class II
Status
Terminated
Quantity
48 beds

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

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

The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

Code information

Serial #'s E510, 506, 503, 515, 518, 10050, 512, 519, E9141, E9150, E9160, E9149, E9137, E5107, E9162, E9165, E9170, E9147, E5323, E520, E9171. E9149, E9516, E9140, 10051, 507, 508, 502, 504, 501, 514, 522, E9139, E10099, E525, 10052, E9148, E9161, E511, E9144, E914, E526, E500, E521, E9166, E530, E529 & E9146.

Distribution pattern

Nationwide Distribution including GA, KY, and MI.

device · product 3 of 3

MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.

Z-1632-2014
Recall number
Z-1632-2014
Initiated
March 18, 2014
Classification
Class II
Status
Terminated
Quantity
83 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

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

The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors.

Code information

Serial #'s 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2061, 2062, 2063, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2094, 2095, 2096, 2097, 2100, 2101, 2102, 2103, 2106, 2107, 2108, 2109, 2110, 2111, 2112, 2113, 2114, 2115, 2116, 2126, 2127, 2128, 2129, 2135, 2136, 2137, 2138, 2139, 2118, 2119, 2120, 2122, 2123, 2124, 2125, 2141, 2142, 2143, 2144, 2145, 2146, 2147, 2148, 2149 & 2150.

Distribution pattern

Nationwide Distribution including GA, KY, and MI.