Recall Z-1658-2009 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
NRT - Nordisk Rontgen Teknik A/S
Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
| Date | Sep 29, 2009 (initiated May 1, 2009) |
| Status | Terminated |
| Reason | The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | An Advisory Notice concerning GE Precision MPi, dated May 1, 2009, was issued to Healthcare Professionals. The notice discussed the problem, risk, recommended immediate action, future actio, and affected system and serial numbers. A GE Field Service Representative will visit each affected U.S. customer site and introduce a speaker connected to the generator touch screen (to which the audible tone is delivered) in the operator's room, to be placed on the wall in the x-ray room. For further information, customers were to contact their local GE field engineer. |
| Quantity | 38 units (US) |
| Distribution | Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033486 | GE PRECISION MPI Nrt-Nordisk Rontgen Teknik A/S, Nov 19, 2003 |