Recalls / —

—#29863

Product

Philips Odyssey VP Workstations, used with Axis, Irix, or Meridian Gamma Camera Systems.

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K003437, K964712

Affected lot / code info

All serial numbers / all models.

Why it was recalled

Due to a software anomaly, an incorrect patient name may be transmitted with image to Odyssey workstation.

Root cause (FDA determination)

Other

Action the firm took

The firm notified their affected consignees by letter on 9/15/2003. The customers were informed how to avoid the problem until a software upgrade is installed on the units.

Recalling firm

Firm

Philips Medical Systems (Cleveland) Inc

Address

595 Miner Rd, Cleveland, Ohio 44143

Distribution

Distribution pattern

The systems were installed at medical facilities located nationwide and worldwide.

Timeline

Recall initiated

2003-09-15

Posted by FDA

2003-11-06

Terminated

2008-10-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #29863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.