Recall Z-0838-2020 ยท JAK System, X-Ray, Tomography, Computed
Imactis
Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only,
| Date | Aug 1, 2019 |
| Status | Open, Classified |
| Reason | The firm has become aware that the sensor cover, a component of the single-use navigation kit may contain microbial contamination. A source of microbial contamination has been identified in a raw product used to manufacture the tip of the cover.This could result in direct exposure of the intra-cardiovascular, intra-lymphatic or neurological system to a level of endotoxin sufficient to produce a pyrogenic response. |
| Root cause | Material/Component Contamination |
| Action | On 7/31/2019, Imactis contacted affected consignees via phone and followed up the phone call with an "Urgent Field Safety Notice" sent via E-Mail. In addition to informing the consignees about the recall , the notice also ask customers to take the following action: 1. Identification and quarantine of the concerned devices, 2. Acknowledgement of receipt of the safety information provided in Annex 1 to be returned to the manufacturer. 3. This safety information must be transmitted to all persons in your facility who may be concerned by the implementation of safety corrective actions or to an |
| Quantity | 122 kits |
| Distribution | US: WI & IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162314 | IMACTIS CT-Navigation system Imactis, Sas, Apr 24, 2018 |