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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