GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures,
FDA device recall Z-0753-2016 · posted 2016-02-24 · Terminated
Recall details
- Recalling firm
- Regulatory Insight, Inc
- Reason for recall
- It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose.
- Action taken
- Nordisk Rontgen Teknik ( NRT ) Planned action to bring defect into compliance: 1.Nordisk Rontgen Teknik A/S (NRT) will contact customers and initiate a software and hardware update to correct the defect. 2.NRT engineers will install the software and perform testing to ensure the software and hardware update was effective. 3.The customer notification letter which includes a statement that NRT will without charge, remedy the defect or bring the product into compliance. For further questions please call (720) 962- 5412.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 43
- Distribution
- US Distribution to the states of :TN, CA, WA, OR, PA, WI, FL, MN, VT, NY, NV, MA, CO, IN, MI, MS and OH.
- Date initiated
- 2008-07-01
- Date posted
- 2016-02-24
- Date terminated
- 2017-07-11
- Location
- Littleton, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GE PRECISION MPI (K033486) | Nrt-Nordisk Rontgen Teknik A/S | 2003-11-19 |