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Health product recall

Trumpf Medizin Surgical Lights (2016-01-28)

Starting date:
January 28, 2016
Posting date:
February 22, 2016
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-57186

Affected Products

  1. TRULIGHT 3000 SURGICAL LIGHT
  2. TRULIGHT 5000 SURGICAL LIGHT
  3. ILED 3 SURGICAL LIGHT
  4. ILED 5 SURGICAL LIGHT
  5. TRUVIDIA

Reason

Manufacturer has received information stating the iLED and TruLight lighting systems have fallen from the central axis. The reported incidents occurred while the lights were being positioned for surgical procedures and have been involved in one injury to a user. The investigation of this issue has determined the root cause is due to the improper installation of the snap ring that can occur when a spring arm is attached to the central axis. The snap ring is located inside the interface and holds the spring arm in place. If the snap ring is installed improperly, the spring arm of the lighting system can descend over time, and eventually fall from the central axis. When the snap ring has been installed properly, the potential for the lighting system to fall does not exist.

Affected products

  1. TRULIGHT 3000 SURGICAL LIGHT

Lot or serial number

All Lots

Model or catalog number

TE300H

TE330

TE551-2

Companies
Manufacturer

Trumpf Medizin Systems GmbH T Co. Kg,

Karl-Zeiss-Str. 7-9,

Saalfeld,

07318

GERMANY



B. TRULIGHT 5000 SURGICAL LIGHT

Lot or serial number

All Lots

Model or catalog number

T131

T300

T310

T500

T510

T510-2

T530

T531

T550

Companies
Manufacturer

Trumpf Medizin Systems GmbH T Co. Kg,

Karl-Zeiss-Str. 7-9,

Saalfeld,

07318

GERMANY



C. ILED 3 SURGICAL LIGHT

Lot or serial number

All Lots

Model or catalog number

1300

1310

1320

1330

1331

1340

1430

337540

337542

337550

337618

Companies
Manufacturer

Trumpf Medizin Systems GmbH T Co. Kg,

Karl-Zeiss-Str. 7-9,

Saalfeld,

07318

GERMANY



D. ILED 5 SURGICAL LIGHT

Lot or serial number

All Lots

Model or catalog number

1500

1500-2

1510

1510-2

337541

337547

337556

Companies
Manufacturer

Trumpf Medizin Systems GmbH T Co. Kg,

Karl-Zeiss-Str. 7-9,

Saalfeld,

07318

GERMANY



E. TRUVIDIA

Lot or serial number

All Lots

Companies
Manufacturer

Trumpf Medizin Systems GmbH T Co. Kg,

Karl-Zeiss-Str. 7-9,

Saalfeld,

07318

GERMANY


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