Regulatory information

Regulatory information

AlignRT was CE marked as a class IIb device in June 2016.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the following manufacturer field safety notices or medical device alerts for this technology:

  • 2014/010/020/601/005 (Vision RT reference: 3010769039-15/10/14‑001‑C). This relates to an issue with the MMI interface (now resolved).

  • 2014/011/018/601/001 (Vision RT reference: 3010769039-051114‑001‑C). This relates to an issue with the AlignRT key-switch (now resolved).

  • 2015/011/018/601/010 (Vision RT reference: 3010769039-11/16/15‑001‑C). This was resolved in March 2017.

  • 2016/007/001/601/008 (Vision RT reference: 3010769039-062416‑001‑C). This was resolved in March 2017.

After the first 2 alerts, a product upgrade was released and installed on all affected devices and the field safety corrective actions are now closed.