Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude o
FDA device recall Z-1658-2009 · posted 2009-09-29 · Terminated
Recall details
- Recalling firm
- NRT - Nordisk Rontgen Teknik A/S
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 38 units (US)
- Distribution
- Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI.
- Date initiated
- 2009-05-01
- Date posted
- 2009-09-29
- Date terminated
- 2009-10-20
- Location
- Hasselager, Denmark
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE PRECISION MPI (K033486) | Nrt-Nordisk Rontgen Teknik A/S | 2003-11-19 |