Mini-Mitter Company, Inc.: Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon

Recall number

Z-0325-2008

Recalling firm

Mini-Mitter Company, Inc.

Product

Actical with Step, Part Number 198-0302-00, Mini Mitter, a Respironics Company, Bend, Oregon

Status

Terminated

Initiated

2007-06-27

Posted

2008-01-17

Terminated

2010-10-20

Reason

Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. If left unaddressed, the issues can lead to permanent communication failure.

Root cause

Software design

Action

A Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession. Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required. Min-Mitter will provide a new one year warranty.

Quantity

403

Distribution

Worldwide

Lot, serial or model codes

Serial Numbers: B100001, B100002, B100003, B100005, B100006, B100007, B100008, B100009, B100023, B100024, B100025, B100026, B100027, B100028, B100029, B100030, B100031, B100032, B100033, B100034, B100035, B100036, B100037, B100038, B100039, B100041, B100042, B100043, B100044, B100045, B100046, B100047, B100048, B100049, B100050, B100051, B100052, B100053, B100054, B100055, B100056, B100057, B100058, B100059, B100060, B100061, B100062, B100063, B100064, B100065, B100066, B100067, B100068, B100069, B100070, B100071, B100072, B100073, B100074, B100075, B100076, B100077, B100078, B100079, B100080, B100081, B100082, B100083, B100084, B100085, B100086, B100087, B100088, B100089, B100090, B100091, B100092, B100093, B100094, B100095, B100096, B100097, B100098, B100099, B100100, B100101, B100102, B100103, B100104, B100105, B100106, B100107, B100108, B100109, B100110, B100111, B100112, B100113, B100114, B100115, B100116, B100117, B100118, B100119, B100120, B100121, B100122, B100123, B100124, B100125, B100126, B100127, B100128, B100129, B100130, B100131, B100132, B100133, B100134, B100135, B100136, B100137, B100138, B100139, B100140, B100141, B100142, B100143, B100144, B100145, B100146, B100147, B100148, B100149, B100150, B100151, B100152, B100153, B100154, B100155, B100156, B100157, B100158, B100159, B100160, B100161, B100162, B100163, B100164, B100165, B100166, B100167, B100168, B100169, B100170, B100171, B100172, B100173, B100174, B100175, B100176, B100177, B100178, B100179, B100180, B100181, B100182, B100183, B100184, B100185, B100186, B100187, B100188, B100189, B100190, B100191, B100192, B100193, B100194, B100195, B100196, B100197, B100198, B100199, B100200, B100201, B100202, B100203, B100204, B100205, B100206, B100207, B100208, B100209, B100210, B100211, B100212, B100213, B100214, B100215, B100216, B100217, B100218, B100219, B100220, B100221, B100222, B100223, B100224, B100225, B100226, B100227, B100228, B100229, B100230, B100231, B100232, B100233, B100234, B100235, B100236, B100237, B100238, B100239, B100240, B100241, B100242, B100243, B100244, B100245, B100246, B100247, B100248, B100249, B100250, B100251, B100252, B100253, B100254, B100255, B100256, B100257, B100258, B100259, B100260, B100261, B100262, B100263, B100264, B100265, B100266, B100267, B100268, B100269, B100270, B100271, B100272, B100273, B100274, B100275, B100276, B100277, B100278, B100279, B100280, B100281, B100282, B100283, B100284, B100285, B100286, B100287, B100288, B100289, B100290, B100291, B100292, B100293, B100294, B100295, B100296, B100297, B100298, B100299, B100300, B100301, B100302, B100303, B100304, B100305, B100306, B100307, B100308, B100309, B100310, B100311, B100312, B100313, B100314, B100315, B100316, B100317, B100318, B100319, B100320, B100321, B100322, B100323, B100324, B100325, B100326, B100327, B100328, B100329, B100330, B100331, B100332, B100333, B100334, B100335, B100336, B100337, B100338, B100339, B100340, B100341, B100342, B100343, B100344, B100345, B100346, B100347, B100348, B100349, B100350, B100351, B100352, B100353, B100354, B100355, B100356, B100357, B100358, B100359, B100360, B100361, B100362, B100363, B100364, B100365, B100366, B100367, B100368, B100369, B100370, B100371, B100372, B100373, B100374, B100375, B100376, B100377, B100378, B100379, B100380, B100381, B100382, B100383, B100384, B100385, B100386, B100387, B100388, B100389, B100390, B100391, B100392, B100393, B100394, B100395, B100396, B100397, B100398, B100399, B100400, B100401, B100402, B100403, B100406, B100407, B100408, B100409, B100410, B100411, B100412, B100413, B100414, B100415, B100416, B100417, B100418, B100419, and B100420

510(k) numbers

["K060919"]

PMA numbers

not on file

Product code

M

Firm FEI

3007223238

Firm city

Bend

Firm state

OR

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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