| | Class 2 Device Recall IMACTIS CTNAVIGATION system |  |
| Date Initiated by Firm | August 01, 2019 |
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| Create Date | January 22, 2020 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0838-2020 |
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| Recall Event ID |
84460 |
| 510(K)Number | K162314 |
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| Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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| Product | 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, |
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| Code Information |
Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22 |
Recalling Firm/
Manufacturer |
Imactis
20 Rue Du Tour De L Eau
St Martin D Heres France
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| For Additional Information Contact | Georges Tabary
33-4580-05580 |
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Manufacturer Reason
for Recall | 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. |
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FDA Determined
Cause 2 | Material/Component Contamination |
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| 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 any department to which the removed products could have been transferred.
4. We recommend that you pay particular attention to the required corrective actions in order to ensure compliance.
Action plan:
1. A new sensor cover has been identified for use with the IMACTIS CT-Navigation system. This is reference 610-797 and manufactured by CIVCO. Therefore, the following actions will be implemented:
2. Customer will complete Annex 1 and send to quality@imactis.com before August 9, 2019.
3. Customer will complete Annex 2 referencing the removed lot numbers and return to the address provided.
4. Upon receipt of your removed kits, IMACTIS will send back the new I10100 navigation kits containing the cover under reference 610-797. |
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| Quantity in Commerce | 122 kits |
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| Distribution | US: WI & IL |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JAK
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