Recalls / —

—#27929

Product

Multidiagnost 97

FDA product code

IZZ — Table, Radiographic, Non-Tilting, Powered

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K912470

Affected lot / code info

The firm utilizes a site number specific to each unit: X1207, X1069, X0668, 76345, 17605, 17436, 6852, 6853, 13709, 13971, 6935, 13608, 13951, 6981, 6993, 35481, 86113, 38023, 41372, 62666, 62667, 38897, 37995, 59497, 62936, 62504, 62885, 62988, 62937, 74057, 38657, 38530, 38500, 74056, 59633, 45014, 45013, 47166, 40940

Why it was recalled

Spontaneous movement of table without input from an operator

Root cause (FDA determination)

Other

Action the firm took

On 2/20/02 the firm issued Field Change Order to their field personnel, instructing them to visit each site and upgrade each unit.

Recalling firm

Firm

Philips Medical Systems

Address

22100 Bothell Everett Highway, Bothell, Washington 98041

Distribution

Distribution pattern

The firm distributed units to hospitals and medical centers located throughout the US.

Timeline

Recall initiated

2002-02-20

Posted by FDA

2003-09-12

Terminated

2005-04-11

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #27929. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.