Recalling firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Distribution
Domestic: Nationwide Distribution; International: Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, FrenchPolynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Laos, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nige
Product quantity
111 units (31 US, 80 OUS)
Initiated by
Voluntary: Firm initiated
Code / lot info
System Code: 722038; UDI: 00884838054226; System Serial Number: 71, 115, 42, 108, 173, 119, 60, 37, 38, 99, 130, 48, 157, 41, 141, 137, 49, 63, 35, 167, 55, 70, 39, 62, 46, 118, 67, 78, 120, 7, 106, 102, 169, 11, 89, 117, 40, 105, 113, 110, 5, 134, 88, 64, 112, 143, 94, 109, 73, 166, 147, 31, 3, 127, 92, 135, 32, 69, 121, 123, 98, 129, 79, 14, 148, 153, 122, 164, 111, 160, 171, 172, 159, 155, 144, 163, 152, 168, 161, 158, 156, 138, 162, 132, 95, 116, 45, 9, 150, 146, 90, 27, 91, 154, 104, 124, 30, 136, 72, 93, 66, 140, 75, 50, 68, 58, 54, 47, 36, 170, 29;
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.