Recall Z-1622-2023 ยท JAK System, X-Ray, Tomography, Computed
PHILIPS HEADQUARTERS CAMBRIDGE
Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
| Date | May 23, 2023 (initiated Apr 12, 2023) |
| Status | Open, Classified |
| Reason | Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required |
| Root cause | Software design |
| Action | Philips issued Urgent Medical Device Correction Letters on 4/12/23 US consignees via Certified United States Postal Service (USPS) with delivery confirmation. International global markets were notified of the issue and instructed to distribute the FSN to affected consignees in accordance with local requirements. Letter states reason for recall, health risk and action to take: Refer to the IFU of your Incisive CT system to ensure proper use of the Precise Position function (IFU Section 4.9). " If the patient orientation automatically selected by Precise Position (see Figure 2) is inconsiste |
| Quantity | 7 units US and 76 unit OUS |
| Distribution | AR, CA, OK, TX Foreign: Country Argentina Australia Austria China Colombia Czech Republic Dominican Rep France Germany Guadeloupe Hong Kong India Japan Kuwait Latvia Lithuania Netherlands Norway Portugal Romania Spain Switzerland Taiwan Thailand United Kingdom Vietnam |
| FDA record | Open on fda.gov |