SCM True Air Technologies LLC: Medical Device Recall in 2014 - (Recall #: Z-1632-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 18, 2014

Date Posted: May 28, 2014

Recall Number: Z-1632-2014

Event ID: 67924

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.

Status: Terminated

Product Quantity: 83 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated