Z-2177-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2025
- Initiation Date
- June 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 units
Product Description
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems
Reason for Recall
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
Distribution Pattern
Worldwide - US Nationwide and Puerto Rico and the country of Canada.
Code Information
UDI: 00724995203245: Serial Numbers: 0400224028, 0401625167, 0401625171, 0401625180, 0401625185, 0401625190, 0402022165, 0402022169, 0402422003, 0402622007, 0402925148, 0403122053, 0403122057, 0403125009, 0403223079, 0403223083, 0403223087, 0403223091, 0403321066,0403321070, 0403423063, 0403423067, 0403423071, 0403423075, 0403423079, 0403423083, 0403423087, 0404022003, 0404622011, 0404622014, 0404622017, 0404622020, 0404622023, 0404822104, 0405025032, 0405924100, 0405924103, 0406624134, 0406624138, 0406624142, 0406722052, 0406722056, 0406722060, 0406722064, 0406823005, 0407625022, 0408025008, 0408222120, 0408222124, 0408222128, 0408222132, 0408922093, 0408922097, 0408922101, 0409622008, 0409822014, 0409822018, 0410822042, 0410822046, 0410823068, 0410923149, 0410923152, 0410923155, 0413223057, 0413223060, 0414223170, 0414223174, 0414223178, 0414223182, 0414223186, 0414223190, 0414223194, 0414223198, 0414323003, 0414323006, 0415223065, 0415223068, 0415223071, 0415223074, 0415923036, 0416924069, 0416924074, 0417422053, 0418023091, 0418023095, 0418023099, 0418023103, 0418023107, 0418023111, 0419223082, 0419523010, 0419724177, 0419924007, 0420223048, 0420223051, 0420223054, 0420223057, 0420223060, 0420823170, 0421322041, 0421322045, 0421623206, 0421623211, 0421623216, 0421623221, 0421623226, 0421623231, 0421623236, 0421623241, 0422923010, 0423023059, 0423023304, 0423023307, 0423023379, 0423023384, 0423023389, 0423023394, 0423023399, 0423023451, 0423422042, 0423422045, 0423422048, 0423924004, 0424224127, 0424224131, 0424323096, 0426223004, 0426223008, 0427922038, 0427922042, 0428824102, 0428924075, 0428924079, 0428924083, 0429823019, 0429823023, 0430323199, 0430523194, 0430523197, 0430722034, 0431123070, 0432324031, 0432324156, 0432324159, 0432324162, 0432324165, 0432722064, 0433724005, 0433724010, 0433724015, 0434023084, 0434023087, 0434023090, 0434023111, 0434023116, 0434023121, 0434622027, 0434622031, 0434622035, 0434722013, 0434722159, 0434722163, 0436223068, 0436624179, 0436624184, 0436624189, 0436624194;