—#73504

Product

GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033486
Affected lot / code info: serial numbers: 507001, 507002, 507003, 507004, 507005, 507006, 507007, 507008, 510001, 510002, 510003, 510004, 510005, 510006, 510007, 510008, 510009, 510010, 513001, 513002, 513004, 513005, 513006, 513007, 513008, 513009, 513010, 513011, 518002, 518003, 518004, 518005, 518006, 518007, 518008, 518009, 518010, 518011, 518012, 518013, 518014, 518015, 518016, 518017, 518018, 518019, 518020, 522001, 522002, 522003, 522004, 522005, 522006, and 522008.

Why it was recalled

The Precision MPi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Field Engineers visited affected customers to make the correction.

Recalling firm

Firm: GE Healthcare
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,

Timeline

Recall initiated: 2008-05-01
Posted by FDA: 2008-09-19
Terminated: 2011-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73504. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.