Health product recall

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

  1. O-SPOT
  2. S-SPOT
  3. 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