FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0838-2020
- Recalling firm
- Imactis
- 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,
- Status
- Open, Classified
- Initiated
- 2019-08-01
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- Quantity
- 122 kits
- Distribution
- US: WI & IL
- Lot, serial or model codes
- Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22
- 510(k) numbers
- ["K162314"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 3015060224
- Firm city
- Heres
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28