Terminated

MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

FDA Recall Z-0126-2021 · Posted None

Recalling FirmInvivo Corporation

Recall StatusTerminated

Product CodeMOS

Date Initiated2020-09-14

Date Terminated2023-08-14

Product Quantity12,764 units

Reason for Recall

The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress.

Firm Action

The firm, Philips Invivo, an " URGENT - Field Safety Notice" dated 9/14/20 to its customers. The notice described the product, problem and actions to be taken. Although the symbol on the label should not be have been included, the device poses no risk to users of these devices nor patients. Customers need take no action other than the following: -Notify all members of your staff who need to be aware of the contents of this communication. -Complete and e-mail the Acknowledgement Form included in this letter. email completed form to: [email protected] -Immediate corrections are taking place to remove IPX1 symbols from labels for future use. A Ship Hold and Market Hold were placed on the product in order to contain affected product not yet shipped. If you need any further information or support concerning this issue, please contact your local Philips representative: North America: 1-877-Invivo-1 option 3 (1-877-468-4861, option #3)

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide Distribution: AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NY, OK, OH, PA, PR, RI, SC, TN, TX, VA, VT, WA, WI, and WV; and the countries of: Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Martinique, Mexico, Moldova, Monaco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, and Yemen.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K1620011.5T and 3.0T 16 CH GE Shoulder CoilsInvivo Corporation · 2016-08-31 K1031491.5T 16-CHANNEL HAND-WRIST COILInvivo Corporation · 2011-01-03 K053017MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILSInvivo Corporation · 2005-11-16 K033567MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILSMri Devices Corp. · 2003-11-25

Official Source

View FDA Recall →

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