Z-0838-2020Class II

Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref...

Name: Z-0838-2020 Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref...
Creator: Imactis
Published: 2019-08-01
License: https://open.fda.gov/license/

Imactis, SAS / initiated 2019-08-01 / Open, Classified / root cause: manufacturing process

FDA source

Imactis began a recall of 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... on 2019-08-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0838-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-01
Posted: 2020-01-22
Recalling firm: Imactis, SAS
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,
Product code: JAK System, X-Ray, Tomography, Computed
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 122 kits
Distribution: US: WI & IL
Product codes and lots: Lot # 18120001/Exp. 2020-04-01 and Lot # 19040001/Exp. 2021-01-22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0838-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0838-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-01-29	2020-01-22

Product code JAK

K162314Class IIIMACTIS CT-Navigation systemImactis, Sas / cleared 2018-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)