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Terminated

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.

FDA Recall Z-1055-2019 · Posted None

Recalling FirmPhilips North America, LLC
Recall StatusTerminated
Product CodeKPR
Date Initiated2019-02-28
Date Terminated2020-08-03
Product Quantity1969

Reason for Recall

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.

Firm Action

On February 28, 2019, the firm notified customers via an Urgent Field Safety Notice letter. The letter informed customers that the affected systems would be inspected for missing locking plates. Customers were asked to place a copy of the Field Safety Notice with the documentation of the system until the system has been inspected by Philips. Philips will inspect all potentially affected systems free of charge. If a locking plate is found missing, Philips will secure the system until a locking plate is installed so that use of the system can continue. You will be contacted by your local Philips representative to schedule the inspection. Philip's action will start effective from March 2019. If you need further information or support concerning this issue, please contact your local Philips representative.

Root Cause

Component design/selection

Distribution Pattern

US Nationwide domestic distribution, and worldwide international distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050151MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc. · 2005-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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