Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Reported: August 9, 2023 Initiated: April 25, 2023 #Z-2259-2023
Product Description
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
Reason for Recall
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Details
- Recalling Firm
- Philips North America
- Units Affected
- 20 units OUS
- Distribution
- Nationwide Foreign: China Algeria Argentina Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Czech Republic Ecuador Egypt France Germany Greece India Indonesia Iran Iraq Israel Italy Japan Jordan Korea, Republic of Kosovo Latvia Macedonia Mexico Moldova Netherlands Nigeria Pakistan Panama Philippines Poland Romania Russian Federation Saint Lucia Saint Pierre and Miquelon Saudi Arabia Serbia Slovakia Spain Sweden Taiwan Thailand Tunisia Turkey Turkmenistan United Kingdom Uzbekistan Viet Nam
- Location
- Cambridge, MA
Frequently Asked Questions
What product was recalled? ▼
Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146. Recalled by Philips North America. Units affected: 20 units OUS.
Why was this product recalled? ▼
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 9, 2023. Severity: Moderate. Recall number: Z-2259-2023.
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