0-SPOT, S-SPOT, and TomoSPOT (2018-06-13)
- Starting date:
- June 13, 2018
- Posting date:
- June 29, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device, Biologic/vaccine
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67132
Affected products
- O-SPOT
- S-SPOT
- TomoSPOT
Reason
Beekley Medical has issued a voluntary recall of specific lots of TomoSPOT and designed for digital skin markers (0-SPOT and S-SPOT) due to the possibility of imaging artifact that may mimic calcifications on patient`s mammograms.
Affected products
A. 0-SPOT
Lot or serial number
- 02021801
- 02051801
- 02071801
- 03231801
- 04031801
- 04091801
- 04241801
- 05311802
Model or catalog number
- 791
- 791S
Companies
- Manufacturer
-
Beekley Medical
1 Prestige Lane
Bristol
06010
Connecticut
UNITED STATES
B. S-SPOT
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 777
- 777S
Companies
- Manufacturer
-
Beekley Medical
1 Prestige Lane
Bristol
06010
Connecticut
UNITED STATES
C. TomoSPOT
Lot or serial number
- 02191801
- 02261801
- 03051801
- 03081801
- 03091801
- 03261801
- 04211801
- 04231801
Model or catalog number
- 782
- 782S
- 783
- 783S
- 784
- 784S
- 785
- 785S
Companies
- Manufacturer
-
Beekley Medical
1 Prestige Lane
Bristol
06010
Connecticut
UNITED STATES