Device product
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Z-2522-2026
Product summary
- Event
- Event 99084
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 285 units
- Official record key
device-enforcement:Z-2522-2026
Official wording
Reason: Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.
Code information: UDI/DI 00884838000407, Serial Numbers: DE79569306, DE79569332, DE79569360, DE79569417, DE79569442, DE79569482, DE79569307, DE79569470, DE79569390, DE79569356, DE79569452, DE79569289, DE79569302, DE79569536, DE79569358, DE79569343, DE79569457, DE79569353, DE79569373, DE79569411, DE79569491, DE79569615, DE79569287, DE79569338, DE79569437, DE79569459, DE79569473, DE79569340, DE79569308, DE79569377, DE79569286, DE79569304, DE79569327, DE79569330, DE79569347, DE79569352, DE79569400, DE79569418, DE79569431, DE79569436, DE79569456, DE79569469, DE79569474, DE79569588, DE79569326, DE79569424, DE79569487, DE79569547, DE79569290, DE79569258, DE79569367, DE79569370, DE79569380, DE79569388, DE79569311, DE79569440, DE79569460, DE79569527, DE79569462, DE79569299, DE79569261, DE79569405, DE79569260, DE79569313, DE79569369, DE79569216,
Distribution pattern: Worldwide distribution - US Nationwide and The countries of AE, AT, AU, BE, BG, BH, BR, CA, CH, CN, CR, CZ, DE, ES, FI, FR, GB, GR, HK, ID, IL, IN, IT, JO, JP, KR, KR, LT, LU, LV, MX, MY, NL, NZ, OM, SA, SE, SG, SI, TR, TW, ZA.
Derived failure modes
-
Manufacturing or process control
incorrect assembly