Terminated

da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.

FDA Recall Z-1385-2015 · Posted 2015-04-06

Recalling FirmIntuitive Surgical, Inc.

Recall StatusTerminated

Product CodeKKX

Date Initiated2015-03-16

Date Terminated2015-12-03

Product Quantity442,475 total all drape models

Reason for Recall

Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.

Firm Action

Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050322MICROTEK EQUIPMENT DRAPESMicrotek Medical, Inc. · 2005-05-17

Official Source

View FDA Recall →

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