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Health product recall

Nakanishi Surgery Handpieces (2015-07-09)

Starting date:
July 7, 2015
Posting date:
March 16, 2017
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-62664

Affected Products

A. TI95EX Contra

B. TI-MAX X Contra/HP

C. TI-MAX Z Contra/HP

D. S-MAX M Contra/HP

E. TI-MAX Z45 Contra

F. Micro Surgery Handpiece SGA

G. Micro Surgery Handpiece SGS

H. TI-MAX X-SG Contra

Reason

Nakanishi updated the operation manual to include clarifications and details regarding the proper maintenance of the handpieces, and how proper maintenance can reduce the risk of injury to patients.

Affected products

A. TI95EX Contra

Lot or serial number

All serial numbers

Model or catalog number

TI95EX

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN



B. TI-MAX X Contra/HP

Lot or serial number

All serial numbers

Model or catalog number

X85

X85L

X95

X95EX

X95L

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN



C. TI-MAX Z Contra/HP

Lot or serial number

All serial numbers

Model or catalog number

Z85L

Z95L

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN



D. S-MAX M Contra/HP

Lot or serial number

All serial numbers

Model or catalog number

M95

M95L

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN



E. TI-MAX Z45 Contra

Lot or serial number

All serial numbers

Model or catalog number

Z45L

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN



F. Micro Surgery Handpiece SGA

Lot or serial number

All serial numbers

Model or catalog number

SGA-E2S

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN



G. Micro Surgery Handpiece SGS

Lot or serial number

All serial numbers

Model or catalog number

SGES

SGSE2S

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN



H. TI-MAX X-SG Contra

Lot or serial number

All serial numbers

Model or catalog number

XS93

XSG93L

Companies
Manufacturer

NAKANISHI INC.

700 SHIMOHINATA

KANUMA-SHI, TOCHIGI-KEN

322-8666

JAPAN