Recall Z-1829-2012— Philips Healthcare Inc.

Name: FDA recall Z-1829-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-21

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-05-21, terminated 2017-01-18. It names 2 FDA 510(k) clearances: K050151, K023441. Product: Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography. Reason: MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-05-21
Terminated: 2017-01-18
Firm location: Andover, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K050151 — MULTIDIAGNOST ELEVAPhilips Medical Systems North America, Inc.·cleared 2005-02-09
K023441 — PHILIPS MULTIDIAGNOST ELEVAPhilips Medical Systems·cleared 2002-10-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography

Reason for recall

MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement

Data sourced from openFDA. This site is unofficial and independent of the FDA.