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Health product recall

HDI 5000 System (2014-12-03)

Starting date:
December 3, 2014
Posting date:
December 18, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-42933

Recalled Products

HDI 5000 System

Reason

Philips can no longer service or replace the MPT7-4 Transesophageal Echocardiograph (TEE) transducer, and in particular, Philips can no longer procure a key service part of the transducer, and the performance of this part may degrade with time and use, leading to a reduction in the range of articulation of the transducer. Philips is providing customers with a field safety notice to notify customers of the issue and provide Philips' current general recommendations for testing and operational procedures for tee transducers.

Affected products

HDI 5000 System

Lot or serial number

011C9N
011C9R
011CBW
011CJT
011CKB
011D0R
02H4GD
02QQG1

Model or catalog number

8500-8457-XX

Companies
Manufacturer
Philips Ultrasound Inc.
22100 Bothell-Everett Highway,
Bothell
98021-8431
Washington
UNITED STATES