Table 2.
FDA Determined Causes, Radiation Oncology vs. All Other Class 2 Device Recalls
| FDA Determined Cause | Radiation Oncology Devices (n=502) | Other Class 2 Devices (n=9,534)* | ||
|---|---|---|---|---|
| Count | Percent | Count | Percent | |
| Software | 246 | 49.0 | 958 | 10.0 |
| Device Design/Change Control | 84 | 16.7 | 991 | 10.4 |
| Other/Under Investigation | 81 | 16.1 | 3,163 | 33.2 |
| Labeling | 24 | 4.8 | 675 | 7.1 |
| Material/Component | 21 | 4.2 | 1,138 | 11.9 |
| Process | 20 | 4.0 | 1,024 | 10.7 |
| Component | 15 | 3.0 | 357 | 3.7 |
| Employee/Use Error | 7 | 1.4 | 297 | 3.1 |
| Radiation Control for Health and Safety Act | 3 | 0.6 | 110 | 1.2 |
| Equipment Maintenance | 1 | 0.2 | 111 | 1.2 |
| Packaging | 0 | 0.0 | 507 | 5.3 |
*
For brevity, the following determined causes were omitted, as 0% of ROD recalls and <1% of other device recalls cited them: Counterfeit, Environmental control, PMA, Reprocessing Controls, Storage, Vendor change control