Generic Name: (1) To (5) Superconducting Magnet-type Whole-body Mri Systems; (6) Combined Mri-pet Systems — Trade Names: (1) Optima Mr450w — (2) Signa Pioneer — (3) Signa Voyager — (4) Discovery Mr750 — (5) Discovery Mr750w — (6) Signa Pet/mr
- Recalling firm
- Name of Manufacturer/Distributor: GE Healthcare Japan Co., Ltd. — Address of Manufacturer/Distributor: 4-7-127 Asahigaoka, Hino City, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: （1）オプティマ MR450w 製造番号 ： EM0101、EM0103、EM0104、EM0105、EM0106、EM0107、EM0108、EM0109、EM0110、EM0111、 EM0112、EM0113、EM0114、EM0115、EM0116、EM0117、EM0118、EM0119、EM0120、EM0121、 EM0122、EM0123、EM0124、EM0125、EM0126、EM0127、EM0128、EM0129、EM0130、EM0131、 EM0132、EM0133、EM0134、EM0135、EM0136、EM0137、EM0138、EM0139、EM0140、EM0141、 EM0142、EM0145、EM0150、EM0151、EM0152、EM0153、EM0155、EM0170、EM0177、EM0200、 EM0800、EM0801、EM0802、EM0803、EM0804、EM0805、EM0806、EM0807、EM0808、EM0809、 EM0810、EM0811、EM0812、EM0813、EM0814、EM0815、EM0900、EM0901、EM0902、EM0905、 EM0907、EM0911、EM0915、EM0917、EM0918、EM0921、EM0924、EM0925、EM0926、EM0930、...
- Reason
- We have been informed by the manufacturer that, for certain units equipped with removable patient tables, the routine functional checks of the patient table caster locks—which are performed during regular maintenance—may not have been carried out. Therefore, based on information from the manufacturer, we are notifying our customers and conducting functional tests of the patient table caster locks; if any issues are identified, we will perform corrective maintenance to address them.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a4b9f9da-411b-4473-8faf-45d0aa920bc3