Recall Z-0694-2019 ยท LNH System, Nuclear Magnetic Resonance Imaging
Philips Medical Systems Nederlands
Ingenia Elition S, Ingenia Elition X
| Date | Dec 3, 2018 |
| Status | Terminated |
| Reason | During automatic tabletop movement, pressing and holding the Stop Table button may lead to an unexpected restart of the table movement. |
| Root cause | Under Investigation by firm |
| Action | On December 4, 2018, the firm notified customers of the recall via an Urgent Medical Device Correction letter. The letter informed customers of the product issue. Customers were asked to do the following: The user must follow the Instructions for Use to verify that no part of the patient's body, hair, clothing, cables or infusion lines can get trapped or injured by any part of the equipment. Additionally, the VitalScreen shows positioning guidance regarding arm supports and padding. The user should avoid the use of the yellow Stop Table button on the VitalScreen. The user must always use th |
| Quantity | 35 |
| Distribution | CA, MN, NJ, NY, OH, TN, TX. Foreign distribution to Canada, Belgium, France, Germany, INdia, Japna, Netherlands, South Africa, Sweden, Switzerland, UAE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173356 | Ingenia Elition S and Ingenia Elition X R5.4 Philips Medical Systems Nederland B.V., Mar 6, 2018 |