Navigator Probes Wireless, Navigator Probes Wired, Navigator Probes (2019-09-18)
- Starting date:
- September 18, 2019
- Posting date:
- October 3, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71117
Last updated: 2019-10-03
Affected Products
- Navigator Probes Wireless
- Navigator Probes Wired
- Navigator Probes
Reason
Dilon revised the navigator probes cleaning and disinfecting instructions approving certain sterilization methods. A supplemental instructions for use was provided to the install base and distributor (importer) informing them of the change. Use of sterilization is determined by the user and use of a sterile drape is still recommended per the IFU.
Affected products
A. Navigator Probes Wireless
Lot or serial number
Not applicable - all codes.
Model or catalog number
- N2-9000-14
- N2-9000-14S
Companies
- Manufacturer
-
Dilon Technologies, Inc.
12050 Jefferson Avenue, suite 340
Newport News
23606-4471
Virginia
UNITED STATES
B. Navigator Probes Wired
Lot or serial number
Not applicable.
Model or catalog number
- SP-2A14-67
- SP-2S10-31
- SP-2S10-31D
- SP-2S11-53
- SP-2S14-67
Companies
- Manufacturer
-
Dilon Technologies, Inc.
12050 Jefferson Avenue, suite 340
Newport News
23606-4471
Virginia
UNITED STATES
C. Navigator Probes
Lot or serial number
Not applicable.
Model or catalog number
- SP-2A14-67
- SP-2S10-31
- SP-2S10-31D
- SP-2S11-53
- SP-2S14-67
Companies
- Manufacturer
-
Dilon Technologies, Inc.
12050 Jefferson Avenue, suite 340
Newport News
23606-4471
Virginia
UNITED STATES