FDA has not published a risk classification for this recall yet.
- Recall #:
- 98748
- Lot/product code:
- 1. System Code Description: Azurion 3 M12. Model Number [UDI]: 722221 [(01)00884838099203(21)181, (01)00884838099203(21)178, (01)00884838099203(21)93]; 722229 [(01)00884838116726(21)22, (01)00884838116726(21)9, (01)00884838116726(21)16, (01)00884838116726(21)15, (01)00884838116726(21)5, (01)00884838116726(21)3, (01)00884838116726(21)4, (01)00884838116726(21)6, (01)00884838116726(21)2, (01)00884838116726(21)8].
2. System Code Description: Azurion 3 M15. Model Number [UDI]: 722222 [(01)00884838099210(21)358, (01)00884838099210(21)328, (01)00884838099210(21)389, (01)00884838099210(21)378, (01)00884838099210(21)243, (01)00884838099210(21)392, (01)00884838099210(21)396, (01)00884838099210(21)13, (01)00884838099210(21)379, (01)00884838099210(21)385, (01)00884838099210(21)376, (01)00884838099210(21)366, (01)00884838099210(21)365, (01)00884838099210(21)398, (01)00884838099210(21)274]; 722230 [(01)00884838116733(21)40, (01)00884838116733(21)2, (01)00884838116733(21)41, (01)00884838116733(21)15, (01)00884838116733(21)28, (01)00884838116733(21)38, (01)00884838116733(21)9, (01)00884838116733(21)27, (01)00884838116733(21)13].
3. System Code Description: Azurion 5. Model Number [UDI]: 722281 [(01)00884838110564(21)401, (01)00884838110564(21)427, (01)00884838110564(21)382, (01)00884838110564(21)425].
4. System Code Description: Azurion 5 M12. Model Number [UDI]: 722227 [(01)00884838099227(21)265, (01)00884838099227(21)360, (01)00884838099227(21)320, (01)00884838099227(21)338, (01)00884838099227(21)324, (01)00884838099227(21)305, (01)00884838099227(21)356, (01)00884838099227(21)346, (01)00884838099227(21)313, (01)00884838099227(21)339, (01)00884838099227(21)321, (01)00884838099227(21)247, (01)00884838099227(21)298, (01)00884838099227(21)337, (01)00884838099227(21)306, (01)00884838099227(21)336, (01)00884838099227(21)318, (01)00884838099227(21)353, (01)00884838099227(21)309, (01)00884838099227(21)310, (01)00884838099227(21)316, (01)00884838099227(21)272, (01)00884838099227(21)345, (01)00884838099227(21)351, (01)00884838099227(21)352, (01)00884838099227(21)258, (01)00884838099227(21)326, (01)00884838099227(21)348, (01)00884838099227(21)355, (01)00884838099227(21)315, (01)00884838099227(21)280, (01)00884838099227(21)300, (01)00884838099227(21)335, (01)00884838099227(21)344, (01)00884838099227(21)308, (01)00884838099227(21)362, (01)00884838099227(21)323, (01)00884838099227(21)331, (01)00884838099227(21)269, (01)00884838099227(21)294, (01)00884838099227(21)342, (01)00884838099227(21)330, (01)00884838099227(21)340, (01)00884838099227(21)284, (01)00884838099227(21)333, (01)00884838099227(21)253, (01)00884838099227(21)301, (01)00884838099227(21)332, (01)00884838099227(21)334, (01)00884838099227(21)297, (01)00884838099227(21)350, (01)00884838099227(21)307, (01)00884838099227(21)311, (01)00884838099227(21)319, (01)00884838099227(21)286, (01)00884838099227(21)329, (01)00884838099227(21)208, (01)00884838099227(21)178]; 722231 [(01)00884838116740(21)52, (01)00884838116740(21)49, (01)00884838116740(21)50, (01)00884838116740(21)41, (01)00884838116740(21)21, (01)00884838116740(21)53, (01)00884838116740(21)47, (01)00884838116740(21)3, (01)00884838116740(21)25, (01)00884838116740(21)34, (01)00884838116740(21)61, (01)00884838116740(21)26, (01)00884838116740(21)7, (01)00884838116740(21)8, (01)00884838116740(21)4, (01)00884838116740(21)5, (01)00884838116740(21)12, (01)00884838116740(21)60, (01)00884838116740(21)28, (01)00884838116740(21)45, (01)00884838116740(21)20, (01)00884838116740(21)19, (01)00884838116740(21)51, (01)00884838116740(21)29, (01)00884838116740(21)27, (01)00884838116740(21)11, (01)00884838116740(21)35, (01)00884838116740(21)62, (01)00884838116740(21)54, (01)00884838116740(21)33, (01)00884838116740(21)1, (01)00884838116740(21)2, (01)00884838116740(21)32].
5. System Code Description: Azurion 5 M20. Model Number [UDI]: 722228 [(01)00884838099234(21)481, (01)00884838099234(21)537, (01)00884838099234(21)615, (01)00884838099234(21)538, (01)00884838099234(21)533, (01)00884838099234(21)522, (01)00884838099234(21)600, (01)00884838099234(21)642, (01)00884838099234(21)573, (01)00884838099234(21)659, (01)00884838099234(21)567, (01)00884838099234(21)645, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)569, (01)00884838099234(21)616, (01)00884838099234(21)568, (01)00884838099234(21)629, (01)00884838099234(21)566, (01)00884838099234(21)571, (01)00884838099234(21)647, (01)00884838099234(21)562, (01)00884838099234(21)640, (01)00884838099234(21)676, (01)00884838099234(21)677, (01)00884838099234(21)602, (01)00884838099234(21)461, (01)00884838099234(21)613, (01)00884838099234(21)393, (01)00884838099234(21)660, (01)00884838099234(21)673, (01)00884838099234(21)580, (01)00884838099234(21)668, (01)00884838099234(21)623, (01)00884838099234(21)486, (01)00884838099234(21)487, (01)00884838099234(21)396, (01)00884838099234(21)172, (01)00884838099234(21)575, (01)00884838099234(21)398, (01)00884838099234(21)392, (01)008… (truncated, 47171 characters total — see the official FDA record for the full value)
- Recalling firm:
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.