Reported Apr 3, 2019 · Terminated

MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I…

Philips North America, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Philips North America, LLC · 3000 Minuteman Rd · Andover, MA · 01810-1032

- MultiDiagnost Eleva w/ Flat Detector
- Product codes 708034
- 708037
- 708038
Product UsageAs 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 areasDigestive
systemSwallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic
Shunts (TIPS) Skeletal systemBone studies
Urinary systemIVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy
tube replacement Reproductive systemHysterosalpingogram, Vena spermatica
Cavernography Respiratory systemThorax, Bronchoscopy
Pulmonary biopsies Circulatory systemVenography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement
VariousArthrograms, Myelograms, Facet joint injections, Discography, Sialography

Lot codes and dates: 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
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Amount recalled: 1969

The agency filed one notice per product. You are reading one of them; the other 5 are below.

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.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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35 in total.