GE Healthcare, LLC Recall 90587
Description: SIGNA Premier magnetic resonance scanner, model 5748519.
GE Healthcare, LLC Recall 90587 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1430-2022 |
| Event ID | 90587 |
| Event Description | SIGNA Premier magnetic resonance scanner, model 5748519. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom. |
| Quantity | 52 |
| Recall Reason | Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss. |
| Device Classification | 20220727 |
| Device Code Info | SIGNA Premier GTINs: 00840682135269 and 00195278010797 |
| Center Classification Date | 20220721 |
| Recall Initiation Date | 20220624 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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