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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93819

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 11, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
PHILIPS MEDICAL SYSTEMS

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

CombiDiagnost R90 1.0 (709030)

Z-1087-2024
Recall number
Z-1087-2024
Initiated
February 11, 2022
Classification
Class II
Status
Ongoing
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
86 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

Code information

Model: R90 1.0 (709030); UDI DI: 00884838076747; Software version 1.1.1 or higher; Serial numbers: 10000000, 10000002, 10000003, 10000004, 10000006, 10000011, 10000012, 10000020, 10000024, 10000027, 10000049, 10000050, 10000065, 10000066, 10000067, 10000069, 10000078, 10000081, 10000099, 10000103, 10000107, 10000140, 10000145, 10000152, 10000180, 10001001, 10001010, 10001095, 591362, SN16000009, SN17000003, SN17000007, SN17000015, SN17000022, SN17000111, SN17000114, SN17000118, SN17000120, SN17000121, SN17000122, SN17000123, SN17000128, SN17000129, SN17000130, SN17000145, SN17000146, SN17000147, SN17000148, SN17000153, SN17000157, SN17000163, SN17000165, SN17000166, SN18000003, SN18000004, SN18000010, SN18000021, SN18000025, SN18000033, SN18000037, SN18000038, SN18000044, SN18000045, SN18000053, SN18000054, SN18000057, SN18000060, SN18000068, SN18000069, SN18000079, SN19000004, SN19000006, SN19000011, SN19000020, SN19000034, SN19000036, 27, 40, 41, 42, 77, 101, 131, 155, 180, 190;

Distribution pattern

US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.

device · product 2 of 2

CombiDiagnost R90 1.1 (709031)

Z-1088-2024
Recall number
Z-1088-2024
Initiated
February 11, 2022
Classification
Class II
Status
Ongoing
Recalling firm
PHILIPS MEDICAL SYSTEMS
Quantity
130 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

Code information

Model: R90 1.1 (709031); UDI DI: 00884838101456; Software version 1.1.1 or higher; Serial Numbers: 10001004, 10001005, 10001006, 10001008, 10001009, 10001010, 10001011, 10001012, 10001013, 10001018, 10001020, 10001022, 10001024, 10001026, 10001027, 10001028, 10001029, 10001030, 10001031, 10001032, 10001035, 10001036, 10001043, 10001044, 10001045, 10001046, 10001047, 10001048, 10001049, 10001050, 10001051, 10001052, 10001053, 10001054, 10001055, 10001056, 10001057, 10001058, 10001059, 10001060, 10001061, 10001062, 10001063, 10001064, 10001065, 10001066, 10001067, 10001068, 10001069, 10001070, 10001071, 10001072, 10001073, 10001074, 10001075, 10001076, 10001077, 10001078, 10001079, 10001080, 10001081, 10001083, 10001084, 10001085, 10001086, 10001087, 10001088, 10001089, 10001090, 10001091, 10001092, 10001093, 10001094, 10001095, 10001096, 10001097, 10001098, 10001099, 10001100, 10001101, 10001102, 10001103, 10001104, 10001105, 10001106, 10001107, 10001108, 10001109, 10001110, 10001111, 10001112, 10001113, 10001114, 10001115, 10001116, 10001117, 10001118, 10001119, 10001120, 10001121, 10001122, 10001123, 10001124, 10001125, 10001126, 10001127, 10001128, 10001129, 10001130, 10001131, 10001132, 10001133, 10001134, 10001135, 10001136, 10001137, 10001138, 10001139, 10001140, 10001141, 10001142, 10001143, 10001144, 10001145, 10001147, 10001148, 10001149, 10001150, 10001152, 10001201;

Distribution pattern

US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.