FDA Device recall Z-1055-2019
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging applicat…
- FDA Device
- Class II
- terminated
- Published 2019-04-03
On 2019-04-03 the FDA classified a Class II recall of MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging applicat… by Philips North America, citing the locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1055-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-28 |
| Published | 2019-04-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips North America |
| Distribution | US |
Product
MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.
Reason
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Identifiers
| code_info | Serial numbers 1 2 2 2 3 3 4 4 4 5 5 5 6 6 6 7 7 8 8 8 9 9 10 10 10 11 11 12 12 12 13 1…Serial numbers 1 2 2 2 3 3 4 4 4 5 5 5 6 6 6 7 7 8 8 8 9 9 10 10 10 11 11 12 12 12 13 13 13 14 14 14 15 15 15 16 16 17 17 18 18 19 19 20 21 22 22 22 23 23 23 24 24 24 25 25 25 26 26 26 27 27 28 28 29 29 29 30 30 30 31 31 31 32 32 32 33 33 33 34 34 34 35 35 35 36 36 36 37 37 38 38 38 39 39 39 40 40 41 41 41 42 42 43 43 43 44 44 44 45 45 46 46 47 47 47 48 48 48 49 49 50 50 50 51 51 51 52 52 53 53 53 54 54 54 55 55 56 56 57 57 58 58 59 60 60 60 61 61 62 62 63 63 63 64 64 64 65 65 65 66 66 67 67 68 68 69 69 69 70 70 71 71 71 72 72 72 73 73 73 74 75 75 76 76 76 77 78 78 79 79 79 80 80 80 81 81 81 82 82 83 83 83 84 84 85 85 86 87 88 88 88 89 90 90 91 91 92 92 93 93 93 94 94 94 95 95 95 96 96 96 97 97 97 98 98 98 99 99 100 100 100 101 101 101 102 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1055-2019%22
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