Recalls / —

—#45462

Product

MD4 X-ray system

FDA product code

JAA — System, X-Ray, Fluoroscopic, Image-Intensified

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K961374

Affected lot / code info

Site numbers 102550 (20279385), 103023, 38783, 102562 (20279430), 83957, 101155, 82628, 38442, 83038, 13721, 85034, 102583, 80306, 41156, 38993, 84930, X1321, 41032, X1077, 100014, 50328, 17656, 83367, 38586, 100954, 76834, 87176, 41426, 104137, 82800, 103651, 10388, 41111, 17622, 13918, 103377, 101038, X0934, 102034, 52471, 76804, 50251, 44898, 13258, 86545, 101863, 38587, 103043 (20283876), 82688, 38635, 47160, 14099, 45042, 38917, 101156 (20278521), 86328, 38501, 13879, 41439, 41069, 76975, X1277, 100637, X1078, 35484, 101759, 84463, 105022, X1751, 76877, 13172, 38944, 41143, 85694, 87140, 59546, 13704, 10458, 45039, 76869, 52455, 84892, 41271, 87302, 6842, 41031, 41000, X0662, 87030, 76808, 6838, 62938, 86218, 85491, 50340, 82687, 38912, 101153, 103210

Why it was recalled

Potential for unexpected table movement.

Root cause (FDA determination)

Other

Action the firm took

On 4/6/06 the firm issued a letter to consignees advising of the problem. The letter advises consignees to conduct a test on their unit(s) for a possible short until the firm is able to upgrade the units.

Recalling firm

Firm

Philips Medical Systems North America Co. Phillips

Address

22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern

Units were distributed to hospitals and medical centers located throughou the US.

Timeline

Recall initiated

2006-04-06

Posted by FDA

2006-05-06

Terminated

2008-05-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #45462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.