Imactis recalls
Every recall we track for Imactis — 3 in all, from 2019–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for Imactis since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 1 | 0 | 0 | 1 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Imactis product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Imactis recalls
3 shown- Use cautionMedical device
Imactis recalls Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
Imactis recalls NaviKit stereotaxic accessories for CT systems due to a needle holder defect that may cause inaccurate needle placement, risking organ damage. Affected units include specific lots and reference numbers.
ImactisFeb 11, 2021 - Use cautionMedical device
Imactis recalls Imactis Patient Fiducial (Patient Referential), REF: IHR-YY-XXX component used in conjunction with the
Imactis recalls patient fiducial components used with CT navigation workstations due to separation risks causing navigation inaccuracies. All units are affected.
ImactisAug 24, 2020 - Use cautionMedical device
Imactis recalls Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482,
Imactis recalls navigation kits with potential microbial contamination in sensor covers, risking pyrogenic responses. Affected kits include specific model numbers and expiration dates.
ImactisAug 1, 2019
Imactis recall questions
How many recalls has Imactis had?
3 recalls from Imactis are on record with U.S. safety agencies, from 2019–2021.
What is the most recent Imactis recall?
Imactis recalls Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100, dated Feb 11, 2021. Every Imactis recall is listed on this page, newest first.
What should I do if I have a recalled Imactis product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Imactis recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.