Z-2261-2023 Class II Ongoing
FDA device recall Z-2261-2023 was initiated by Philips North America on April 25, 2023 and is designated Class II. 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 i… The recall status is ongoing. Affected quantity: 6 units OUS.
Recall Details
- Product Type
- Devices
- Report Date
- August 9, 2023
- Initiation Date
- April 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units OUS
Product Description
Reason for Recall
Distribution Pattern
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