BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is perform
FDA device recall Z-2577-2023 · posted 2023-09-11 · Open, Classified
Recall details
- Recalling firm
- PTW-FREIBURG
- Reason for recall
- Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS Detector 1000 or OCTAVIUS Detector 1600, if a Tiff file or a DICOM data set is used as reference matrix. Therefore, the measurement result will be incorrect by using such a calibration file.
- Action taken
- PTW North America notified US End users via email and attached Urgent Medical Device Correction letter from PTW Freiberg on 8/23/23. Letter states reason for recall, health risk and action to take: PTW does not recommend performing a relative calibration of the OD 1000 and OD 1600 using Tiff files and DICOM data sets and recommends using alternative reference matrices. A correct result can also be generated if the reference matrix for relative calibration is rotated 90 counterclockwise in VeriSoft and saved before loading into ArrayCal. The information mentioned above should be observed by the customer. No further action is required. Pass this notice on to everyone at your facility/hospital or at another facility/hospital where the equipment is located who needs to know about it.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- IYE
- Quantity affected
- 42 US
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-06-07
- Date posted
- 2023-09-11
- Location
- Freiburg Im Breisgau, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D (K160405) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten | 2017-10-20 |